Methods and apparatus for treating disorders of the ear nose and throat

ABSTRACT

A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/193,020, filed Jul. 29, 2005, published as U.S. Pat. Pub.No. 2006/0063973, published on Mar. 23, 2006, which is acontinuation-in-part of U.S. patent application Ser. No. 10/829,917,filed Apr. 21, 2004, now U.S. Pat. No. 7,654,997, issued on Feb. 2, 2010U.S. patent application Ser. No. 10/944,270, filed Sep. 17, 2004, nowabandoned, U.S. patent application Ser. No. 11/116,118, filed Apr. 26,2005, now U.S. Pat. No. 7,720,521, issued on May 18, 2010, and U.S.patent application Ser. No. 11/150,847, filed Jun. 10, 2005, now U.S.Pat. No. 7,803,150, issued on Sep. 28, 2010, each such application beingexpressly incorporated herein by reference. This application claims thebenefit of Provisional Application Ser. No. 61/098,157, filed Sep. 18,2008, the contents of which are incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus andmethods. More specifically, the invention relates to devices and methodsfor accessing and dilating openings of the paranasal sinuses.

BACKGROUND

Functional endoscopic sinus surgery (FESS) is currently the most commontype of surgery used to treat chronic sinusitis. In a typical FESSprocedure, an endoscope is inserted into the nostril along with one ormore surgical instruments. The surgical instruments are then used to cuttissue and/or bone, cauterize, suction, etc. In most FESS procedures,the natural ostium (e.g., opening) of at least one paranasal sinus issurgically enlarged to improve drainage from the sinus cavity. Theendoscope provides a direct line-of-sight view whereby the surgeon istypically able to visualize some but not all anatomical structureswithin the surgical field. Under visualization through the endoscope,the surgeon may remove diseased or hypertrophic tissue or bone and mayenlarge the ostia of the sinuses to restore normal drainage of thesinuses. FESS procedures can be effective in the treatment of sinusitisand for the removal of tumors, polyps and other aberrant growths fromthe nose.

The surgical instruments used in the prior art FESS procedures haveincluded; applicators, chisels, curettes, elevators, forceps, gouges,hooks, knives, saws, mallets, morselizers, needle holders, osteotomes,ostium seekers, probes, punches, backbiters, rasps, retractors,rongeurs, scissors, snares, specula, suction canulae and trocars. Themajority of such instruments are of substantially rigid design.

In order to adequately view the operative field through the endoscopeand/or to allow insertion and use of rigid instruments, many FESSprocedures of the prior art have included the surgical removal ormodification of normal anatomical structures. For example, in many priorart FESS procedures, a total uncinectomy (e.g., removal of the uncinateprocess) is performed at the beginning of the procedure to allowvisualization and access of the maxilary sinus ostium and/or ethmoidbulla and to permit the subsequent insertion of the rigid surgicalinstruments. Indeed, in most traditional FESS procedures, if theuncinate process is allowed to remain, such can interfere withendoscopic visualization of the maxillary sinus ostium and ethmoidbulla, as well as subsequent dissection of deep structures using theavailable rigid instrumentation.

More recently, new devices, systems and methods have been devised toenable the performance of FESS procedures and other ENT surgeries withminimal or no removal or modification of normal anatomical structures.Such new methods include, but are not limited to, uncinate-sparingBalloon Sinuplasty™. procedures and uncinate-sparing ethmoidectomyprocedures using catheters, non-rigid instruments and advanced imagingtechniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these newdevices, systems and methods are described in incorporated U.S. patentapplication Ser. No. 10/829,917 entitled Devices, Systems and Methodsfor Diagnosing and Treating Sinusitis and Other Disorders of the Ears,Nose and/or Throat, now U.S. Pat. No. 7,654,997, issued on Feb. 2, 2010;Ser. No. 10/944,270 entitled Apparatus and Methods for Dilating andModifying Ostia of Paranasal Sinuses and Other Intranasal or ParanasalStructures, now abandoned; Ser. No. 11/116,118 entitled Methods andDevices for Performing Procedures Within the Ear, Nose, Throat andParanasal Sinuses filed Apr. 26, 2005, now U.S. Pat. No. 7,720,521,issued on May 18, 2010, and Ser. No. 11/150,847 entitled Devices,Systems And Methods Useable For Treating Sinusitus, filed on Jun. 10,2005, now U.S. Pat. No. 7,803,150 issued on Sep. 28, 2010.

Though the Balloon Sinuplasty™ system has led to great advances inparanasal sinus treatments, further development and refinement of thesystem and methods for using it are continually being sought. Forexample, it would be desirable to have a system that is simpler than thecurrent system for physicians to use, especially for physicians who arenew to the system. Ideally, such a simplified system could be used andmanipulated by one user and not require an assistant, at least in somecases. Also ideally, such a system would be simply packaged in a waythat was convenient for the user. At least some of these objectives willbe met by the present invention.

SUMMARY

The various embodiments disclosed herein provide apparatus, systems andmethods for accessing and dilating paransal sinus openings. Generally,each of the various embodiments combines two or more surgicalinstruments or instrument features into a device (or system) that can beheld in one hand, thus helping to free up the other hand of the userand/or to make a procedure easier to perform. For example, in oneembodiment a guide and a balloon catheter may be coupled together via ahandle. In some embodiments, a guidewire and/or an endoscope may also becoupled with the balloon catheter and/or the handle. The various devicesand methods of these various embodiments may be used separately or inany possible and desirable combinations with each other.

In accordance with one embodiment, a device for dilating an ostium of aparanasal sinus of a human or animal subject includes a handle and anelongate shaft having a proximal end coupled with the handle andextending to a distal end. The shaft includes a lumen and a longitudinalopening extending from the lumen to an outer surface of the shaft alongat least part of a length between the proximal and distal ends. Thisembodiment also includes a guidewire disposed through at least a portionof the shaft lumen and a dilator having a non-expanded configuration andan expanded configuration, wherein at least a portion of the dilator isdisposed over the guidewire and within the shaft lumen. A slide memberis also coupled with the guidewire or the dilator through thelongitudinal opening of the shaft for advancing the guidewire and/or thedilator relative to the shaft. In one embodiment, the slide is capableof axial rotation relative to the elongate shaft to rotate the guidewireand/or the dilator. Also, in certain embodiments, the device includes apiercing member coupled with the distal end of the shaft for piercing ahole into a paranasal sinus of the subject, wherein the distal end ofthe shaft is insertable through the hole.

In another embodiment, the device includes a fluid reservoir attached tothe elongate shaft, and the fluid reservoir is in fluid communicationwith the dilator. There may also be a trigger or actuation handlecoupled with the fluid reservoir, and actuating the trigger causes fluidin the fluid reservoir to inflate the dilator into the expandedconfiguration.

In accordance with another embodiment of a device for accessing anostium of a paranasal sinus of a human or animal subject, the deviceincludes a handle and an elongate shaft having a proximal end coupledwith the handle and extending to a distal end. The elongate shaftincludes a longitudinal lumen extending at least partway from theproximal end to the distal end. There is also a device advancing membercoupled with the handle or the elongate shaft and configured to couplewith and advance one device through the lumen of the shaft and at leastpartway into an ostium of a paranasal sinus. In certain embodiments, aguidewire extends through at least part of the elongate shaft lumen, andthe device advancing member is configured to couple with and advance theguidewire through the lumen and through the ostium of the paranasalsinus. In one embodiment, a balloon dilation catheter extends through atleast part of the shaft lumen, wherein the device advancing member isconfigured to couple with and advance the balloon dilation catheterthrough the lumen and at least partway into the ostium of the paranasalsinus.

In accordance with one embodiment of a system for dilating an anatomicalstructure within the ear, nose or throat of a human or animal subject,includes an endoscope and an elongate tubular guide removably coupledwith the endoscope. There is also a handle coupled with at least one ofthe endoscope for grasping the endoscope or the elongate tubular guidein one hand. In one embodiment, a dilator is slidably disposed in theelongate tubular guide, wherein the dilator has a non-expandedconfiguration for passing through the elongate tubular guide and anexpanded configuration for dilating the anatomical structure. In certainembodiments, a first clip is attached to the endoscope and a second clipis attached to the elongate tubular guide. A connection member forconnecting the first and second clips is also included.

In one embodiment, the endoscope and elongate tubular guide, coupledtogether, are sized to pass into a hole punctured into a paranasal sinusof the subject. In this embodiment, the system further includes apiercing member coupled with at least one of the endoscope or theelongate tubular guide for forming the hole.

The system may also include a guidewire disposed through a guidewirelumen extending through at least part of the dilator, and in oneembodiment, a guidewire advancing member coupled with the elongatetubular guide for advancing the guidewire relative to the guide may alsobe included. Still in another embodiment, the system includes anendoscope cleaner coupled with the endoscope. The endoscope cleanerincludes a sheath disposed over at least part of the endoscope and atube coupled with the sheath to connect the sheath with a source ofcleaning fluid.

According to one embodiment of a method for dilating an opening in aparanasal sinus of a human or animal subject, the method includesholding an elongate, tubular, at least partially rigid guide in one handusing a handle, wherein a balloon dilation catheter resides within alumen of the guide and extends through the handle. Also, the methodincludes advancing a distal end of the guide to a position near anopening in a paranasal sinus of a human or animal subject, wherein theballoon catheter resides within the lumen of the guide duringadvancement. Once in position, the method further includes advancing theballoon dilation catheter through the guide to position a balloon of theballoon dilation catheter in the paranasal sinus opening. The balloon ofthe balloon dilation catheter is then expanded to dilate the opening. Inone embodiment, the method may include advancing the balloon dilationcatheter by advancing an advancement member coupled with the handle andthe catheter. Also, in certain embodiments, the method may includeadvancing a guidewire through the distal end of the guide and throughthe opening into the paranasal sinus, wherein the guidewire resideswithin a lumen of the balloon catheter during advancement of the guideinto the subject, and wherein the balloon catheter is advanced throughthe distal end of the guide over the guidewire.

In one embodiment, the method also includes emitting light from a distalend of the guidewire, and viewing the emitted light from outside thesubject to confirm that the distal end of the guidewire is located inthe paranasal sinus before advancing the balloon dilation catheter.

In another embodiment, the guide is advanced through an opening in acanine fossa of the subject's head into a maxillary sinus or through anopening in a wall of the maxillary sinus, the method also includingforming the canine fossa opening or the maxillary sinus wall openingusing a piercing tool.

In yet another embodiment, the method includes holding an endoscope withthe handle, wherein the endoscope and the guide are coupled with thehandle, and wherein the endoscope and the guide are advanced into thesubject. In another embodiment, the endoscope, guide and ballooncatheter are advanced into the subject together. Further, the distal endof the guide or the balloon of the balloon catheter is viewed using theendoscope.

These and other aspects and embodiments are described in further detailbelow, with reference to the accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a perspective view of a human subject undergoing a procedurefor treating sinusitis in accordance with the present invention;

FIG. 2A is a top view of a dilation device useable to dilate the ostiaor paranasal sinuses and other anatomical passages within the ear, noseand throat;

FIG. 2B is a side view of the device of FIG. 27A;

FIGS. 2C-2D show steps in a method for using the dilation device ofFIGS. 27A-27B;

FIG. 2E is a side view of another dilation device useable to dilateopenings of paranasal sinuses and other anatomical passages within theear, nose and throat;

FIG. 2F is a side view of another dilation device which uses compressedinflation fluid to inflate a dilator balloon to dilate openings ofparanasal sinuses and other anatomical passages within the ear, nose andthroat;

FIG. 2G is a schematic diagram of the valving arrangement of the deviceshown in FIG. 27F;

FIG. 2H is a partial sectional view through a portion of the device ofFIG. 27A-B;

FIG. 3A is a perspective view of a hand grip inflator device attached toa balloon catheter;

FIG. 3B is a perspective view of a balloon dilation device having a handgrip inflator;

FIG. 4A is a perspective view of an integrated system including anendoscope attached to a guide catheter;

FIG. 4B is a perspective view of another embodiment of an integratedsystem including an endoscope in connection with a guide catheter;

FIG. 5A is a perspective view of a surgical hand tool useable to dilatethe ostia or paranasal sinuses and other anatomical passages within theear, nose and throat;

FIG. 5B is a cross-section view of the surgical hand tool shown in FIG.5A;

FIG. 6A is a perspective view of another embodiment of a surgical handtool;

FIG. 6B is a cross-section view of the surgical hand tool shown in FIG.6A;

FIG. 7 is a perspective view of another embodiment of a surgical handtool capable of rotating a catheter and a guidewire;

FIG. 8A is a perspective view of yet another embodiment of a surgicalhand tool;

FIG. 8B is a cross-section view of the surgical hand tool shown in FIG.8A;

FIG. 9A is a perspective view of another embodiment of a surgical handtool including a fluid reservoir;

FIG. 9B is a cross-section view of the surgical hand tool shown in FIG.9A;

FIGS. 9C through 9E are schematic views of different embodiments offluid delivery systems for the surgical hand tool shown in FIGS. 9A and9B;

FIG. 10A is a perspective view of another embodiment of a surgical handtool being supported by rails;

FIG. 10B is a perspective view of a proximal end of a surgical handtool;

FIG. 10C is a perspective view of yet another embodiment of a surgicalhand tool including a palm brace;

FIGS. 10D and 10E are perspective views of another embodiment of asurgical hand tool including a guide attachment;

FIG. 11 is a perspective view of a surgical hand tool having a syringemounted to a body of the surgical hand tool for fluid delivery;

FIG. 12A is a perspective view of an irrigation catheter having a sidecut-out;

FIG. 12B is a cross-sectional view taken along line 12B-12B shown inFIG. 12A;

FIG. 13 is a side view of an irrigation catheter having a side cut-outand a single lumen;

FIGS. 14A and 14B are side views of a balloon irrigation catheter havinga side cut-out;

FIG. 15A is a side view an irrigation syringe inserted through a sidewindow of a balloon catheter;

FIG. 15B is a side view of a distal end the irrigation syringe shown inFIG. 15A;

FIG. 16 is a flow diagram of a method for treating sinus disordersincluding holding a guide catheter and balloon catheter in one hand;

FIG. 17 is a flow diagram of a method useable for treating sinusdisorders by removal or modification of an anatomical or pathologicalstructure in combination with dilation of an opening of a paranasalsinus;

FIG. 18 is a flow diagram of a method useable for treating sinusdisorders by dilation of an opening of a paranasal sinus in combinationwith suction and/or irrigation of a sinus cavity;

FIG. 19 is a flow diagram of a method useable for treating conditionswhere unwanted scar or adhesion tissue has formed by forming a puncturetract in the scar or adhesion tissue, inserting a dilator into thepuncture tract and dilating the puncture tract; and

FIG. 20 a flow diagram of a method useable for treating sinus disordersby dilation of a natural opening of a paranasal sinus in combinationwith the creation of a new opening in the paranasal sinus.

DETAILED DESCRIPTION

The following detailed description, the accompanying drawings and theabove-set-forth Brief Description of the Drawings are intended todescribe some, but not necessarily all, examples or embodiments of theinvention. This detailed description and the accompanying drawings areprovided primarily for exemplary purposes and should not be interpretedto limit the scope of the invention as described by the claims. Althoughthe Balloon Sinuplasty™ paranasal sinus procedure is sometimes mentionedin this description, many embodiments of the present invention may beused in performing any other paranasal sinus procedures.

The devices disclosed herein may be used alone or in variouscombinations to perform various procedures including, but not limitedto, various procedures within paranasal sinuses and/or within openingsof paranasal sinuses. As used herein, unless specified otherwise, theterm “opening(s) of paranasal sinus(es)” shall include any opening in aparanasal sinus or air cell including but not limited to: natural ostia,natural canals, surgically altered natural ostia, surgically createdopenings, antrostomy openings, ostiotomy openings, burr holes, drilledholes, puncture tracts, ethmoidectomy openings, fenestrations and othernatural or man made passageways.

FIG. 1 shows a human subject undergoing a Balloon Sinuplasty™ procedurefor treating sinusitis in accordance with one embodiment. The humansubject may be subjected to one or more diagnostic, therapeutic oraccess devices introduced through an optional support device 100. Inmany cases, paranasal sinus procedures of the present invention areperformed without using any support device 100, but such may beconvenient, for example, in performing a procedure in a procedure roomof a physicians clinic or other setting where an assistant is notavailable. One example of a therapeutic device that may be used inprocedures of the present invention is a balloon catheter used to dilateopenings of paranasal sinuses or other endonasal anatomical structures.One example of an access device that may be used in such procedures is aguidewire used to access natural ostia of paranasal sinuses or a naturalor artificial passageway or tract leading to paranasal sinuses. In theembodiment shown in FIG. 1, support device 100 includes a support memberthat is stabilized by three or more legs that rest on the operatingtable. The one or more diagnostic, therapeutic or access devices may betracked or navigated through the anatomy using one or more tracking ornavigation modalities. In the embodiment shown in FIG. 1, a C-armfluoroscope 102 provides fluoroscopic visualization of anatomicalregions during the procedure. An instrument console 104 comprising oneor more functional modules may also be provided. Instrument console 104can be controlled by console control means e.g. a foot pedal controller,a remote controller etc. Instrument console 104 may be fitted withwheels to enable an operator to change the position of the instrumentconsole in an operating area. Instrument console 104 may comprisefunctional modules including, but not limited to:

1. Suction pump for delivering a controlled amount of vacuum to asuction device,

2. Irrigation pump to deliver saline or other suitable irrigationmedium,

3. Power module to supply power to drills or other electrical devices,

4. Storage modules for storing instruments, medications, etc.,

5. Energy delivery module to provide radiofrequency, laser, ultrasoundor other therapeutic energy to a surgical device,

6. Fluoroscope, MRI, CT, Video, Endoscope 106 or Camera or other imagingmodules to connect or interact with devices used during variousdiagnostic or therapeutic procedures,

7. Display module e.g. a LCD, CRT or Holographic screen to display datafrom various modules such as an endoscope, fluoroscope or other data orimaging module,

8. Remote control module to enable an operator to control one or moreparameters of one or more functional modules, and

9. Programmable Microprocessor that can store one or more operationsettings for one or more functional modules etc.

In the embodiment shown in FIG. 1, instrument console 104 is connectedto an endoscope 106. Endoscope 106 may be introduced in the anatomythrough one or more introducing devices 108 such as guide catheters. Aphysician may use a hand held introducer 110 comprising a surgicalnavigation modality to introduce one or more diagnostic, therapeutic oraccess devices into the anatomy. Examples of surgical navigationmodalities that may be located on introducer 110 include, but are notlimited to navigation modalities comprising reflective passive elements,light emitting diodes, transmitters or receivers of energy (e.g. opticalenergy, radiofrequency energy, etc.), a combination of two or more ofthe above-mentioned navigation modalities, etc.

As is evident from the above description, a Balloon Sinuplasty™procedure may involve using a number of different surgical intruments(or “tools”). For example, a physician will typically use an endoscope,a guide, a guidewire, a balloon catheter, an inflation device forinflating the balloon catheter, and a C-arm fluoroscopy device forobserving at least part of the procedure. In some cases, a lightedguidewire (for example, the Relieva Luma™ Sinus Illumination Guidewirefrom Acclarent, Inc.) may be used, in which case a light source isattached to the guidewire during at least part of the procedure.Optionally, a procedure may also include irrigation (cleaning out usingsaline or other fluid) of one or more paranasal sinuses to remove mucusfrom the sinus(es), using for example a irrigation catheter (such as theRelieva Vortex™ Sinus Irrigation Catheter from Acclarent, Inc.).Additionally, in some procedures multiple guides may be used to reachdifferent sinuses, with each guide having a different angle and/or size.Different balloon catheters may also be used, with some balloondiameters being different for different sized paranasal sinus openings.Furthermore, in different cases other instruments may be used, some ofwhich are described, for example, on the Acclarent, Inc. web site(www.acclarent.com). In some instances, therefore, it may be desirableto couple or otherwise combine two or more instruments, features or thelike, in order to simplify a procedure, allow a physician to holdmultiple instruments in one hand, or otherwise facilitate or enhance aparanasal sinus procedure such as (but not limited to) a BalloonSinuplasty™ procedure.

Referring now to FIGS. 2A and 2B, one embodiment of a surgical hand tool200 comprising a balloon catheter is shown in top view (FIG. 2A) andside view (FIG. 2B). In this embodiment, surgical hand tool 200 mayinclude a hollow proximal body 202 made of biocompatible materialsincluding, but not limited to ABS, nylon, polyurethane, polyethylene,etc. Proximal body 202 encloses a balloon catheter 204. Balloon catheter204 comprises a balloon inflation port 206 to inflate a balloon onballoon catheter 204. Balloon inflation port 206 emerges out of proximalbody 202 through a longitudinal slit 208 through proximal body 202 suchthat balloon catheter 204 can slide along the axis of proximal body 202.Balloon inflation port 206 is connected to a suitable inflating deviceto inflate the balloon of balloon catheter 204. In this embodiment,balloon catheter 204 is introduced into a desired region of the anatomyover a guidewire 210. The proximal region of guidewire 210 may comprisea torquing device 212. A user can use torquing device 212 to rotate,advance, retract, or torque guidewire 210. The distal region of proximalbody 202 comprises a suitable hub that allows a guide catheter 214 toattach to proximal body 202. In an alternate embodiment, guide catheter214 is permanently attached to proximal body 202. In this embodiment,guide catheter 214 comprises an elongate tubular element 216 made ofsuitable biocompatible materials including, but not limited to PEEK,Pebax, Nylon, Polyimide, ABS, PVC, polyethylene, etc. The proximalregion of tubular element 216 may be covered by a hypotube 218 made ofsuitable biocompatible metals or polymers. The proximal end of tubularelement 216 is attached to a suitable hub 220. Hub 220 allows thereversible attachment of guide catheter 214 to proximal body 202. In oneembodiment, hub 220 is a female luer lock that attaches to a suitablehub on proximal body 202. Thus, various guide catheters can be attachedto the distal region of proximal body 202 to provide access to variousanatomical regions. The distal end of tubular element 216 may comprisean atraumatic tip 222. The distal end of tubular element 216 maycomprise a curved, bent or angled region. FIG. 2B shows the side view ofsurgical hand tool 200 showing a handle 224 attached to proximal body202.

FIGS. 2C through 2D show various steps of a method of dilating ananatomical region using the surgical hand tool 200 shown in FIGS. 2A and2B. In FIG. 2C, surgical hand tool 200 is introduced in the anatomy.Surgical hand tool 200 is positioned such that the distal tip ofsurgical hand tool 200 is located near an anatomical region to beaccessed. Thereafter, a guidewire 210 is introduced through surgicalhand tool 200 such that the distal tip of guidewire 210 is located nearan anatomical region to be accessed. During this step, guidewire 210 maybe navigated through the anatomy using torquing device 212. In oneembodiment, guidewire 210 is positioned across a paranasal sinus ostiumto be dilated. Thereafter, in FIG. 2D, balloon catheter 204 is advancedover guidewire 210 into the anatomy. This is done by pushing ballooninflation port 206 in the distal direction. Thereafter, balloon catheter204 is used to perform a diagnostic or therapeutic procedure. In oneembodiment, balloon catheter 204 is used to dilate an opening leading toa paranasal sinus such as a paranasal sinus ostium.

FIG. 2E shows a side view of a first alternate embodiment of a surgicalhand tool 226 comprising a balloon catheter. The design of surgical handtool 226 is similar to the design of surgical hand tool 200. Surgicalhand tool 226 comprises a hollow elongate body 227 made of biocompatiblematerials including, but not limited to ABS, nylon, polyurethane,polyethylene, etc. Elongate body 227 is attached to a handle 228 toallow a user to grasp surgical hand tool 226. Elongate body 227comprises a longitudinal slit 229. Elongate body 227 encloses a ballooncatheter 230. Balloon catheter 230 comprises a balloon inflation port231 to inflate a balloon on balloon catheter 230. Balloon inflation port231 emerges out of elongate body 227 through longitudinal slit 229 suchthat balloon catheter 230 can slide along the axis of elongate body 227.Balloon catheter 230 is further connected to a trigger 232. Trigger 232is pivoted on elongate body 227 such that pulling trigger 232 in theproximal direction causes balloon catheter 230 to move in the distaldirection. Similarly, pushing trigger 232 in the distal direction causesballoon catheter 230 to move in the proximal direction. Thus, ballooncatheter 230 can be moved by moving trigger 232. The distal region ofelongate body 227 comprises a suitable hub that allows a guide catheter233 to attach to elongate body 227. In this embodiment, guide catheter233 comprises an elongate tubular element 234 made of suitablebiocompatible materials including, but not limited to PEEK, Pebax,Nylon, polyethylene, etc. The proximal region of tubular element 234 maybe covered by a hypotube 235 made of suitable biocompatible metals orpolymers. The proximal end of tubular element 234 is attached to asuitable hub 236. Hub 236 allows the reversible attachment of guidecatheter 233 to elongate body 227. In one embodiment, hub 236 is afemale luer lock that attached to a suitable hub on elongate body 227.Thus, various guide catheters can be attached to the distal region ofelongate body 227 to provide access to various anatomical regions. Thedistal end of tubular element 234 may comprise an atraumatic tip 237.The distal end of tubular element 234 may comprise a curved, bent orangled region. In this embodiment, balloon catheter 230 is introducedinto a desired region of the anatomy over a guidewire 238. The proximalregion of guidewire 238 may comprise a torquing device 239. A user canuse torquing device 239 to rotate, advance, retract, or torque guidewire238. Surgical hand tool 226 can be used to introduce balloon catheter230 into a desired anatomical region to perform a diagnostic ortherapeutic procedure in the anatomical region.

FIG. 2F shows a side view of a second alternate embodiment of a surgicalhand tool 240 comprising a balloon catheter. The design of surgical handtool 240 is similar to the design of surgical hand tool 226. Surgicalhand tool 240 further comprises a fluid delivery mechanism to deliverinflating fluid for inflating the balloon of balloon catheter 230. Thefluid delivery mechanism comprises an elongate tube 241 connected toballoon inflation port 231. Elongate tube 241 is further connected to afluid reservoir 242. In one embodiment, fluid reservoir 242 comprises apressurized gas such as air, nitrogen, carbon dioxide, etc. The deliveryof fluid from fluid reservoir 242 to balloon catheter 230 is controlledby a valve 243.

FIG. 2H shows partial sectional view of the surgical hand tool 240 shownin FIG. 2F. The proximal region of elongate body 227 compriseslongitudinal slit 229. Elongate body 227 encloses balloon catheter 230.The proximal end of balloon catheter 230 comprises a Y shaped hub. TheY-shaped hub comprises balloon inflation port 231. Balloon inflationport 231 in turn is connected to elongate tube 241. Guidewire 238 enterselongate body 227 through an opening in the proximal end of elongatebody 227.

FIG. 2G shows a perspective view of an embodiment of the valvearrangement of the device shown in FIG. 2F. The valve arrangementcomprises a three way valve 243. In one embodiment, three way valve 243is a three way luer valve. A first arm 244 of three way valve 243 isconnected by elongate tube 241 to fluid reservoir 242. A second arm 245of three way valve 243 is in fluid communication with the balloon ofballoon catheter 230. A third arm 246 of three way valve 243 isconnected to a drain or is open to the atmosphere. Third arm 246 may beconnected to a syringe or a source of vacuum to deflate balloon ofballoon catheter 230. Such an arrangement comprising a syringe or asource of vacuum connected to third arm 246 is especially useful todeflate a non-compliant balloon. Three way valve 243 further comprises acontrol knob 247. In a first position of control knob 247, a fluidcommunication is created between first arm 244 and second arm 245. In asecond position of control knob 247, a fluid communication is createdbetween second arm 245 and third arm 246. A user can turn control knob247 in the first position to inflate the balloon of balloon catheter230. The user can then turn control knob 247 in the second position todeflate the balloon of balloon catheter 230. Other suitable valvearrangements may also be used instead of a three way valve forcontrollably inflating or deflating the balloon of balloon catheter 230.

FIG. 3A shows a perspective view of an embodiment of a handheld ballooncatheter tool 250. Balloon catheter tool 250 comprises a proximal region251. Proximal region 251 comprises a handle 252 to enable a user to holdballoon catheter tool 250. Balloon catheter tool 250 further comprises aballoon catheter shaft 253. In one embodiment, balloon catheter shaft253 extends distally from the distal region of proximal region 251. Inanother embodiment, balloon catheter shaft 253 extends till the proximalend of proximal region 251. Balloon catheter shaft 253 may furthercomprise a hypotube 254 surrounding a region of balloon catheter shaft253. The distal region of balloon catheter shaft 253 comprises aninflatable balloon 255 that can be used to dilate one or more regions ofthe anatomy. Balloon 255 is inflated by a trigger 256 located adjacentto handle 252. Trigger 256 is connected to a plunger that is furtherconnected to an inflating fluid reservoir. Pulling trigger 256 causesthe inflating fluid stored in an inflating fluid reservoir to bedelivered to balloon 255 under pressure. Balloon catheter tool 250 mayfurther comprise a flushing port 257 to flush a lumen of ballooncatheter shaft 253.

During a procedure, a user inflates balloon 255 to a desired pressureusing the inflating fluid stored in the inflating fluid reservoir. Thepressure in balloon 255 can be measured by a pressure sensor or gauge258 that is in fluid communication with the inflating fluid withinballoon 255. Balloon catheter tool 250 may further comprise a ratchetingmechanism 259 to allow a user to pull trigger 256 in incremental steps.This allows the user to inflate balloon 255 in incremental steps.Similarly, balloon catheter tool 250 may comprise a ratcheting mechanismto allow a user to release trigger 256 in incremental steps afterinflating balloon 255. This allows the user to deflate balloon 255 inincremental steps. In one embodiment, balloon catheter tool 250 can beadvanced over a guidewire to a desired target location in the anatomy.In this embodiment, balloon catheter tool 250 may further comprise aproximal guidewire port 260 that is in fluid communication with aguidewire lumen in balloon catheter shaft 253. This enables ballooncatheter tool 250 to be introduced over a guidewire into the anatomy. Inanother embodiment, balloon catheter tool 250 comprises a fixedguidewire 261 at the distal tip of balloon catheter tool 250 to navigateballoon catheter tool 250 through the anatomy. In one embodiment,balloon catheter tool 250 comprises a rotation knob 262. Rotation knob262 allows a user to rotate balloon catheter shaft 253. Balloon cathetertool 250 may further comprise one or more navigational modalitiesincluding, but not limited to radio opaque markers, electromagneticnavigational sensors, etc. The distal region of balloon catheter tool250 may be introduced in the anatomy through a variety of introducingdevices disclosed herein including, but not limited to a guide catheter.

FIG. 3B shows a perspective view of an embodiment of a detachablehandheld balloon catheter inflation tool 270. Detachable inflation tool270 comprises a body 271 comprising a handle 272 to enable a user tohold inflation tool 270. Detachable inflation tool 270 attaches to aballoon catheter 273. In one embodiment, a user is provided with a kitcomprising a detachable inflation tool 270 and multiple ballooncatheters. In the embodiment shown in FIG. 3B, balloon catheter 273comprises an elongate balloon catheter shaft 274. The distal region ofballoon catheter shaft 274 comprises an inflatable balloon 275 that canbe used to dilate one or more regions of the anatomy. The proximalregion of balloon catheter shaft 274 is connected to a suitable hub 276comprising a side port for inflating balloon 275. In one embodiment,balloon catheter shaft 274 comprises a hypotube 277 surrounding a regionof balloon catheter shaft 275. Balloon 275 is inflated by a trigger 278located adjacent to handle 272. Trigger 278 is connected to a plungerthat is further connected to an inflating fluid reservoir. Pullingtrigger 278 causes an inflating fluid stored in the inflating fluidreservoir to be delivered to balloon 255 under pressure. The inflatingfluid is delivered through a fluid delivery port 279 that attaches tothe side port of hub 276. During a procedure, a user inflates balloon275 to a desired pressure using the inflating fluid stored in theinflating fluid reservoir. The pressure in balloon 275 can be measuredby a pressure sensor or gauge 280 that is in fluid communication withthe inflating fluid within balloon 275. Detachable inflation tool 270may further comprise a ratcheting mechanism 281 to allow a user to pulltrigger 278 in incremental steps. This allows the user to inflateballoon 275 in incremental steps. Similarly, detachable inflation tool270 may comprise a ratcheting mechanism to allow a user to releasetrigger 278 in incremental steps after inflating balloon 275. Thisallows the user to deflate balloon 275 in incremental steps. In oneembodiment, the combination of balloon catheter 273 and balloon cathetertool 270 can be advanced over a guidewire to a desired target locationin the anatomy. In this embodiment, balloon catheter tool 270 mayfurther comprise a proximal guidewire port 282 that is in fluidcommunication with a guidewire lumen in balloon catheter shaft 274. Thisenables balloon catheter tool 270 to be introduced over a guidewire 283into the anatomy. In another embodiment, balloon catheter 273 comprisesa fixed guidewire at the distal tip of balloon catheter 273 to navigateballoon catheter 273 through the anatomy. In another embodiment, ballooncatheter 273 comprises a rapid exchange lumen. The rapid exchange lumenenables balloon catheter 273 to be introduced over a suitable guidewire.Balloon catheter tool 270 may further comprise a flushing port 284 toflush a lumen of balloon catheter 273. Balloon catheter tool 270 mayfurther comprises one or more navigational modalities including, but notlimited to radio opaque markers, electromagnetic navigational sensors,etc. The distal region of balloon catheter 273 may be introduced in theanatomy through a variety of introducing devices including, but notlimited to a guide catheter.

The balloon catheter tool 250 of FIG. 3A or the detachable handheldballoon catheter inflation tool 270 of FIG. 3B may be designed toinflate a balloon to a fixed pressure. Alternatively, they may bedesigned to deliver a fixed volume of inflating fluid to inflate aballoon.

Any of the handle assemblies of the tools described herein and in thepatent applications incorporated herein by reference may comprise arotatable handle. Such a rotatable handle may be designed to convert apart of a rotational force exerted by a user to a rectilinear force todraw components of the handle assembly towards each other. Oneembodiment of a rotatable handle is disclosed in U.S. Pat. No. 5,697,159(Lindén) titled “Pivoted hand tool,” the entire disclosure of which isexpressly incorporated herein by reference. Such designs of rotatablehandles may be used for handle assemblies including, but not limited tothe handle 252 and trigger 256 in FIG. 3A, and the handle 272 andtrigger 278 in FIG. 3B, etc.

Referring now to FIG. 4A, one embodiment of a balloon sinuplasty andendoscope integrated system 300 is shown. The integrated system 300includes an endoscope 302 in connection with a guide catheter 304 and aballoon catheter 306. A handle 308 is also included with the system, andthe handle has a shaft 310 with a lumen therethrough. The endoscope 302is shown to include an endoscope handle 312 on a proximal end 314 and isdisposed through the lumen of the shaft 310. In one embodiment, anendoscope sheath 316 is connected to or disposed through the lumen ofthe shaft 310 to cover the elongate shaft of the endoscope 302 forallowing the endoscope lens to be cleaned with fluid without removingthe endoscope from the system or its current position with the body of apatient. To clean the lens of the endoscope 302, a fluid line 318 is incommunication with the endoscope sheath 316, and a fluid valve 320disposed on the fluid line allows the sheath to be flushed at any timeby opening the fluid valve. The endoscope sheath 316 includes anatraumatic tip 321 to prevent damage to the patient and to keep the lensof the endoscope 302 clean. There may also be a frictional seal 315 onthe handle 308 that seals the proximal end of the endoscopic sheath 316to prevent fluid from leaking back through the handle.

The handle 308 includes a front finger cut-out 322 and a back cut-out324, which allows the physician to grasp the handle and the endoscope302 and balance the weight of the endoscope on four fingers to take thepressure off of the thumb. As shown in FIG. 4A, there is also a postcut-out 326 on the top of the handle that allows a light post 328 of theendoscope to exit vertically if the user desires. Alternatively, thelight post 328 of the endoscope 302 can hang straight down or out to theside without being constrained by the handle 308.

Still referring to FIG. 4A, the guide catheter 304 of the integratedsystem 300 includes a hypotube 330 and an elongate tubular element 332extending out of the hypotube. The elongate tubular element 332 may alsoinclude an atraumatic tip 334 at a distal end 336 of the guide catheter.A hub 338 is disposed at a proximal end 340 of the guide catheter 304,and the hub includes a flange 342 and provides an opening for theballoon catheter 306 to enter into the guide catheter 304. The hub 338is also in communication with a suction line 344 that when activated cansuction fluid out of a target area through the guide catheter 304. Theballoon catheter 306 includes a balloon inflation port 346 to inflate aballoon disposed on the balloon catheter. The balloon catheter 306 canslide through the hub 338 and the guide catheter 304. Balloon inflationport 346 is connected to an inflation tubing 349 and a suitableinflating device to inflate the balloon of the balloon catheter 306. Inone embodiment, the balloon catheter 306 is introduced into a desiredregion of the anatomy over a guidewire 348. The proximal region of theguidewire 348 may include a torquing device 350 that can be manipulatedby a user to rotate, advance, retract or torque the guidewire.

To connect the endoscope 302 with the guide catheter 304, an endoscopeclip 352 is disposed on the endoscope sheath 316 and a guide clip 354 isdisposed on the hypotube 330 of the guide catheter 304. In embodimentsthat do not include the endoscope sheath 316, the endoscope clip 352 maybe disposed directly on the elongate shaft of the endoscope. A clipconnector 356 joins the endoscope clip 352 and the guide clip 354together to form the integrated system. In one embodiment, the endoscopeclip 352 and the guide clip 354 are frictionally fit to the sheath 316and the hypotube 330, respectively, and the clips 352 and 354 can berotated and slid in any direction. In another embodiment, one or both ofthe clips 352 and 354 can include a spring latch or other lockingmechanism to lock the clips in place along the devices. It has also beencontemplated that the clips 352 and 354 may include a slit 358 foreasily removing the clips from the endoscope or guide catheter. In oneembodiment, the clip connector 356 is a malleable wire attached to eachclip 352 and 354. The malleable wire allows for relatively easypositioning and prevents spring back. Also, the malleable wire allowsthe guide catheter 304 to be angled in relation to the endoscope 302 foreasy wiring of the targeted sinus. In some embodiments, the clipconnector 356 includes two linkages for stability, however, one linkagemay also be used.

Still referring to FIG. 4A, one embodiment is shown where the tubing318, 344 and 349 is bonded together to prevent the tubes from becomingentangled. However, in other embodiments, any two of the tubes 318, 344or 349 may be bonded together. Still in other embodiments, the tubes318, 344 and 349 are not bonded together.

The integrated system 300 shown in FIG. 4A allows continuousvisualization of patient anatomy, such as a target paranasal sinusostium, with the endoscope in one hand while freeing the user's otherhand for guidewire manipulation and catheter balloon advancement. Thissystem also allows the guide catheter 304 to be positioned and thenremain static at a set position at or near the target sinus to gainstability during the procedure. Further, the handle allows the user tohold the endoscope without resting the entire weight of the endoscope onthe thumb of the user, thus, helping to prevent cramping of the user'shand.

An alternative embodiment of an integrated system 370 is shown in FIG.4B. In this embodiment the handle 308 includes an extension clip 372 forattaching an extension 374 that is connected to the guide catheter 304.In this embodiment, the extension 374 is attached to the flange 342 ofthe hub 338 connected to the guide catheter 304. When the extension 374is attached to the extension clip 372 of the handle 308, the endoscopeis removably connected to the guide catheter 304 and balloon catheter306. As shown in FIG. 4B, the extension 374 includes a double curvedshape that can be held by the user in one hand. It has been contemplatedthat the extension 374 can slide in and out of the extension clip 372,but does not have to be held by the user when the extension is disposedwithin the extension clip.

The integrated systems 300 and 370 of FIGS. 4A and 4B can be used in asimilar manner for dilating an anatomical region. In use, the integratedsystem 300 and 370 is introduced in the anatomy. In one embodiment, theendoscope 302 and guide catheter 304 are introduced together through anostril of a patient and/or through a manmade opening into a paranasalsinus. The endoscope 302 and guide catheter 304 are positioned such thatthe distal tip of guide catheter 304 is located near an anatomicalregion to be accessed and the endoscope can view the targeted anatomicalregion. Thereafter, the guidewire 348 is introduced through guidecatheter 304 such that the distal tip of the guidewire is located nearthe targeted anatomical region. During this step, the guidewire 348 maybe navigated through the anatomy using the torquing device 350. In oneembodiment, the guidewire 348 is positioned across a paranasal sinusostium to be dilated. Thereafter, the balloon catheter 306 is advancedover the guidewire 348 into the anatomy by pushing the balloon catheterin the distal direction. Once the balloon of the balloon catheter 306 iscorrectly positioned, the balloon catheter 306 is used to perform adiagnostic or therapeutic procedure. In one embodiment, the ballooncatheter 306 is used to dilate an opening leading to a paranasal sinussuch as a paranasal sinus ostium. Once the procedure is complete, theintegrated system 300 or 370 is removed from the targeted anatomicalregion and the patient.

Referring now to FIGS. 5A and 5B, one embodiment is shown of a surgicalhand tool 400 incorporating a guide catheter and a balloon catheter. Thesurgical hand tool 400 includes a hollow proximal body 402 made ofbiocompatible materials including, but not limited to ABS, nylon,polyurethane, polyethylene, etc. Proximal body 402 encloses a ballooncatheter 404 (see FIG. 5B). Balloon catheter 404 includes a ballooninflation port 406 to inflate a balloon on the balloon catheter. Theballoon inflation port 406 emerges out of proximal body 402 through alongitudinal opening or slit 408 through proximal body such that ballooncatheter 404 can slide along the axis of proximal body, as best shown inFIG. 5B. Balloon inflation port 406 is connected to a suitable inflatingdevice via an inflation tubing to inflate the balloon of ballooncatheter 404. In this embodiment, the balloon catheter 404 is introducedinto a desired region of the anatomy over a guidewire 410. In theembodiment shown, the guidewire 410 is locked to the balloon catheter404 with a wire lock 412, which is attached to the proximal end of theballoon catheter. The wire lock 412 can be rotated in one direction tolock the guidewire 410 onto the balloon catheter and rotated in theother direction to unlock the guidewire from the balloon catheter. Insome embodiments, the proximal region of guidewire 410 may include atorquing device (not shown) to rotate, advance, retract, or torque theguidewire.

The distal region of proximal body 402 includes a suitable hub 413 thatallows a guide catheter 414 to attach to proximal body 402. In analternate embodiment, the guide catheter 414 is permanently attached toproximal body 202. In this embodiment, the guide catheter 414 includesan elongate tubular element 416 made of suitable biocompatible materialsincluding, but not limited to PEEK, Pebax, Nylon, Polyimide, ABS, PVC,polyethylene, etc. The proximal region of the tubular element 416 may becovered by a hypotube 418 made of suitable biocompatible metals orpolymers. The proximal end of tubular element 416 is attached to the hub413. The hub 413 allows the reversible attachment of the guide catheter414 to proximal body 402. In one embodiment, the hub 413 is a femaleLuer lock that attaches to a suitable hub on the proximal body 402.Thus, various guide catheters can be attached to the distal region ofthe proximal body 402 to provide access to various anatomical regions.The distal end of tubular element 416 may comprise an atraumatic tip422. In certain embodiments, the distal end of tubular element 416 maycomprise a curved, bent or angled region.

As shown in FIGS. 5A and 5B, the surgical hand tool 400 includes a slideor device advancing member 424 that is disposed partially within theproximal body 402. The slide 424 includes a generally cylindrical body426 that holds the balloon catheter 404 at the inflation port 406 and issized to prevent the slide from falling out of the proximal body 402.Moving the slide advances the balloon catheter 404 and guidewire 410together when the guidewire is locked onto the balloon catheter. Anysteering of the balloon catheter 404 and/or guidewire 410 is achieved bymoving the surgical hand tool 400. There is a first grip 428 and asecond grip 430 for users with different sized hands to reach and movethe slide 424. A back cap 432 is disposed at the proximal end of theproximal body 402 to prevent the slide 424 from being removed from theproximal body. In the embodiment shown, a handle 434 attached to theproximal shaft 402 includes a finger guard 436 that allows the fingersof the user to be pressed forward if desired for extra control.

In an alternative embodiment to the one shown in FIGS. 5A and 5B, hollowproximal body 402 may be replaced my a rail body. The rail would providea structure along which slide 424 could slide and catheter 404 and/orguidewire 410 could be advanced.

Another embodiment of a surgical hand tool 440 is shown in FIGS. 6A and6B. The surgical hand tool 440 is similar to the surgical hand tool 400shown in FIGS. 5A and 5B, however, surgical hand tool 440 is designed toallow the balloon catheter and guidewire to rotate using the slide. Asshown in FIGS. 6A and 6B, the surgical hand tool 440 includes a hollowproximal body 442 made of biocompatible materials including, but notlimited to ABS, nylon, polyurethane, polyethylene, etc. Proximal body442 encloses a balloon catheter 444 (see FIG. 6B). Balloon catheter 444includes a balloon inflation port 446 to inflate a balloon disposed onthe balloon catheter. The balloon inflation port 446 emerges out ofproximal body 442 through a slot or longitudinal opening 448 cut throughthe proximal body such that balloon catheter 444 can slide along theaxis of proximal body, as best shown in FIG. 5B. Balloon inflation port446 is connected to a suitable inflating device via an inflation tubingto inflate the balloon of balloon catheter 444. In this embodiment, theballoon catheter 404 is introduced into a desired region of the anatomyover a guidewire 450. In the embodiment shown, the guidewire 450 islocked to the balloon catheter 404 by a wire lock 452, which is attachedto the proximal end of the balloon catheter. The wire lock 452 can berotated in one direction to lock the guidewire 450 onto the ballooncatheter and rotated in the other direction to unlock the guidewire fromthe balloon catheter. In some embodiments, the proximal region ofguidewire 450 may include a torquing device (not shown) to rotate,advance, retract, or torque the guidewire.

The distal region of the proximal body 442 includes a suitable hub 453that allows a guide catheter 454 to connect to the proximal body 442. Inan alternate embodiment, the guide catheter 454 is permanently attachedto the proximal body 442. In this embodiment, the guide catheter 454includes an elongate tubular element 456 made of suitable biocompatiblematerials including, but not limited to PEEK, Pebax, Nylon, Polyimide,ABS, PVC, polyethylene, etc. The proximal region of the tubular element456 may be covered by a hypotube 458 made of suitable biocompatiblemetals or polymers. The proximal end of tubular element 456 is attachedto the hub 453. The hub 453 allows the reversible attachment of theguide catheter 454 to the proximal body 442. In one embodiment, the hub453 is a female luer lock that attaches to a suitable hub on proximalbody 442. Thus, various guide catheters can be attached to the distalregion of proximal body 442 to provide access to various anatomicalregions. The distal end of tubular element 456 may comprise anatraumatic tip 462. In certain embodiments, the distal end of tubularelement 456 may comprise a curved, bent or angled region.

As shown in FIGS. 6A and 6B, the surgical hand tool 440 includes a slideor device advancement member 464 that moves within the proximal body442. The slide 464 includes a generally cylindrical bottom portion 466that holds the balloon catheter 444 at the inflation port 446 and issized to prevent the slide from falling out of the proximal body 442.Moving the slide advances the balloon catheter 444 and guidewire 450together when the guidewire is locked onto the balloon catheter. Thesize of the slot or longitudinal opening 448 in this embodiment allowsthe user to rotate, and hence steer, the balloon catheter and guidewirewith the slide between about thirty to sixty degrees in both directionsfor a total rotational freedom of between about sixty and one-hundredand twenty degrees. However, the rotation of the slide can be from aboutzero degrees to about ninety degrees in both directions for a totalfreedom of rotation between about zero degrees and about one-hundred andeighty degrees. Steering may also be accomplished by moving the surgicalhad tool 440. In this embodiment, there are multiple grips 468 extendingfrom the slide 464 on either or both sides for user's with differentsized hands to reach and move the slide 424. A mount 469 of the slide464 attaches the grips 468 together. In another embodiment, the grips468 could be replaced with loops that extend over the proximal body 442.A back cap 472 is disposed at the proximal end of the proximal body 442to prevent the slide 464 from being removed from the proximal body. Inthe embodiment shown, a handle 474 attached to the proximal shaft 442includes a finger guard 476 that allows the fingers of the user to bepressed forward if desired for extra control.

In this embodiment shown in FIGS. 6A and 6B, the surgical hand tool alsoincludes a mount bottom 478 attached towards the proximal end of theslide 464 to allow for the longest possible travel of the ballooncatheter 444 along the proximal body 442. There is also a cut-out 480 onthe proximal body 442 that allows the slide 464 to be rotate a few extradegrees to allow removal and replacement of the balloon catheter withanother balloon catheter. When the slide 464 is rotated into the cut-out480, the balloon catheter can be removed from the cylindrical bottomportion 466 of the slide. With the slide still in this position, anotherballoon catheter may be inserted into the cylindrical bottom portion 466of the slide for use with the surgical hand tool.

Another embodiment of a surgical hand tool 490 is shown in FIG. 7 and issimilar to the embodiment shown in FIGS. 6A and 6B. In this embodiment,the proximal body is replaced with a rail 492 that allows greaterrotation of a slide 494. The rotation of the slide 494 can range fromabout one-hundred and fifty degrees to about two-hundred and eightydegrees of total rotational freedom. The slide 494 includes overheadloops 496 that constrain the slide to the rail 494 and provide grips forthe user to move the slide along the rail, which in turn moves a ballooncatheter 498 and guidewire 500 locked by a wire lock 502.

Yet another embodiment of a surgical hand tool 510 is shown in FIGS. 8Aand 8B, which allows one handed control of the balloon sinuplastydevice. The surgical hand tool 510 includes a hollow proximal body 512made of biocompatible materials including, but not limited to ABS,nylon, polyurethane, polyethylene, etc. Proximal body 512 encloses aballoon catheter 514 (see FIG. 8B). Balloon catheter 514 includes aballoon inflation port 516 to inflate a balloon disposed on the ballooncatheter. The balloon inflation port 516 emerges out of proximal body512 through a longitudinal slit or opening 518 through the proximal bodysuch that balloon catheter 404 can slide along the axis of the proximalbody. Balloon inflation port 516 is connected to a suitable inflatingdevice via an inflation tubing to inflate the balloon of ballooncatheter 514. In this embodiment, the balloon catheter 514 is introducedinto a desired region of the anatomy over a guidewire 520.

The guidewire 520 is fed through a proximal loop 522 attached to theproximal end of the proximal body 512, over a wire ramp 524, and into awire slot 526 of the proximal body. The guidewire 520 is positionedabove the proximal body 512 allowing a user to control the guidewirebehind the guide catheter using a thumb and index finger. The proximalloop 522 prevents the guidewire from drifting to the left or right, andcan be rotated around the proximal body 512. The wire ramp 524 keeps theposition of the guidewire 520 and is used to hold the guidewire duringballoon catheter advancement. Passing through the wire slot 526, theguidewire 520 enters the balloon catheter 514 through an opening 528 onthe side of the balloon catheter. This type of catheter, such as a rapidexchange catheter, is known in the art.

The distal region of the proximal body 512 includes a suitable hub 530that allows a guide catheter 532 to attach to the proximal body 512. Inan alternate embodiment, the guide catheter 532 is permanently attachedto the proximal body 512. In this embodiment, the guide catheter 532includes an elongate tubular element 534 made of suitable biocompatiblematerials including, but not limited to PEEK, Pebax, Nylon, Polyimide,ABS, PVC, polyethylene, etc. The proximal region of the tubular element534 may be covered by a hypotube 536 made of suitable biocompatiblemetals or polymers. The proximal end of tubular element 534 is attachedto the hub 530. The hub 530 allows the reversible attachment of theguide catheter 532 to proximal body 512. In one embodiment, the hub 530is a female Luer lock that attaches to a suitable hub on proximal body512. Thus, various guide catheters can be attached to the distal regionof proximal body 512 to provide access to various anatomical regions.The distal end of tubular element 534 may comprise an atraumatic tip538. In certain embodiments, the distal end of tubular element 534 maycomprise a curved, bent or angled region. It has also been contemplatedthat guide catheter 532 is frictionally fit into the hub 530 such thatthe guide catheter has the ability to rotate within the hub, but stillhave enough friction in the mechanism to allow it to stay in place onceproperly adjusted.

As shown in FIGS. 8A and 8B, the surgical hand tool 510 includes aballoon driver 540 that is disposed partially within the proximal body512 and extends through the longitudinal slit or opening 518. Theballoon driver 540 includes a balloon driver latch 542 (FIG. 8B) thatholds the balloon catheter 514 at the inflation port 516. Moving theballoon driver 540 in the distal direction advances the balloon catheter514 forward. When advancing the balloon catheter forward, the guidewire520 can be held against the ramp 524. Any steering of the ballooncatheter and/or guidewire is achieved by moving the surgical hand tool510. In the embodiment shown, a handle 544 attached to the proximalshaft 512 includes a front portion 546 that is gripped preferably by thefourth and fifth fingers of the user for stabilization. When holding thedevice, the user's palm is preferably pressed against a back portion 548of the handle for stabilization.

The surgical hand tool 510 shown in FIGS. 8A and 8B allows the user tohold the device in the palm of the hand, balance the device withpreferably the fourth and fifth fingers, and advance the guidewire 520with the index finger and thumb. In this manner, the surgical hand tool510 is held in the same hand that is used to control the guidewire 520.Further, the user has direct access to the guidewire giving full tactilefeel during advance and steering of the guidewire. Balloon catheter 514advancement is then achieved by reaching back with the thumb and pushingthe balloon driver 540 forward (distally). The guidewire can then beretracted using the index finger and thumb, and the balloon catheter 514can be retracted by pulling the balloon driver 540 in the proximaldirection.

Still further, another embodiment of a surgical hand tool 550 is shownin FIGS. 9A and 9B, which allows one handed control of the balloonsinuplasty device and fluid delivery to an inflation device. Thesurgical hand tool 550 includes a hollow proximal body 552 made ofbiocompatible materials including, but not limited to ABS, nylon,polyurethane, polyethylene, etc. Proximal body 552 encloses a ballooncatheter 554 (see FIG. 9B). Balloon catheter 554 includes a ballooninflation port 556 to inflate a balloon disposed on the ballooncatheter. The balloon inflation port 556 emerges out of proximal body552 through a longitudinal slit or opening 558 in the proximal body suchthat balloon catheter 554 can slide along the axis of proximal body. Theballoon inflation port 556 also extends through and is held by a balloondriver or device advancement member 560 that is used to move the ballooncatheter in both the distal and proximal directions. A handle 562 of theballoon driver 560 can be turned to either side of the surgical handtool 550 depending on the user's desire, and can be clamped in placewhen a fluid line is attached to the inflation port 556 of the ballooncatheter 554. In this embodiment, the balloon catheter 554 is introducedinto a desired region of the anatomy over a guidewire 558.

An inflation balloon (not shown) disposed on a distal region of theballoon catheter 554 can be used to dilate one or more regions of theanatomy. The balloon is inflated from an unexpanded configuration to anexpanded configuration by an actuation handle or trigger 560 attached tothe proximal body 552. The actuation handle 560 is connected to aplunger 562 that is further connected to a fluid barrel 564 including aninflation fluid reservoir 566. Fluid (water, saline, etc.) stored in theinflation fluid reservoir 566 can be used to inflate the balloon of theballoon catheter, to flush a vortex, or provide fluid wherever desired.During a procedure, a user inflates the balloon of the balloon catheterto a desired pressure using the inflating fluid stored in the inflationfluid reservoir 566. The pressure in the balloon can be measured with apressure sensor or gauge (not shown) that is in fluid communication withthe inflating fluid within the balloon. In one embodiment, the surgicalhand tool 550 is designed to inflate the balloon of the balloon catheterto a fixed pressure. Alternatively, the tool may be designed to delivera fixed volume of inflating fluid to inflate the balloon.

The fluid barrel 564 includes a barrel port 568 that provides astructure for attaching a fluid line 570 from the fluid barrel to theballoon catheter 554 and the inflating balloon. In other embodiments,the barrel port 568 may extend at an angle and from any location on thefluid barrel. The fluid line 570 extends from the barrel port 568 to theinflation port 556 of the balloon catheter in this embodiment.

The actuation handle 560 is designed to accommodate one to three fingersof the user depending on the user's comfort and hand size. In additionto actuating the fluid mechanism of this device, the actuation handleacts to stabilize the device during placement of the guidewire,deploying the balloon, vortex deployment, or deployment of otherdevices. As shown in FIGS. 9A and 9B, the handle includes an outerfinger flange 572 to provide a structure to stabilize the device forusers with larger hands. The outer finger flange can also allow a userto provide extra torque if needed or required for actuating the fluidmechanism. A rotating hinge 574 attached between the actuating handle560 and the plunger 562 delivers the motion and applied force of theactuating handle to the plunger. In other embodiments, the rotatinghinge can be curved to more easily reach into the fluid barrel 564during actuation of the handle 560 and avoid constraints. It has alsobeen contemplated that the pivot points on the hinge 574, actuatinghandle 560, and plunger 562 can be moved closer or farther apartdepending on the distance traveled of the plunger versus rotation of thehandle and applied torque is desired or required. The actuation handlepivot point 575 attaches the handle to the proximal body 552. Tomaximize the distance the plunger travels and the amount of torqueapplied with the handle, the handle pivot point is disposed level withthe center of the connection between the rotating hinge 574 and theplunger 562.

In one embodiment, a spring (not shown) may be embedded in the proximalbody 552 of the device to bias the actuation handle 560 back into anextended or open position away from the fluid barrel 564 after thehandle has been squeezed to inflate the balloon of the balloon catheter.The spring may be a torsion spring disposed around the handle pivotpoint 575 or around a handle/hinge pivot 577. Alternatively, the springmay be a leaf spring disposed between two members or points of thedevice, such as points 575 and 577. Still in other embodiments, thespring may be a coiled spring (tension or compression).

As shown in FIGS. 9A and 9B, the surgical hand tool 550 also includes aback handle 576 that rests against a user's palm Unlike the handles ofother embodiments, the back handle 576 is open at the bottom, whichallows a user to more freely manipulate the device.

In the embodiment shown in FIGS. 9A and 9B, the guidewire 558 is fedthrough a proximal loop 580 attached to the proximal end of the proximalbody 552, over a wire ramp 582, and into a wire slot 584 of the proximalbody. The guidewire 558 is positioned above the proximal body 552allowing a user to control the guidewire behind the guide catheter. Theproximal loop 580 prevents the guidewire from drifting to the left orright, and can be rotated around the proximal body 552. The wire ramp582 keeps the position of the guidewire 582 and is used to hold theguidewire during balloon catheter advancement. Passing through the wireslot 584, the guidewire 558 enters the balloon catheter 554 through anopening 586 on the side of the balloon catheter. This type of catheter,such as a rapid exchange catheter, is known to those skilled in the art.

The distal region of the proximal body 552 includes a suitable hub 590that allows a guide catheter 592 to attach to the proximal body 552. Inone embodiment, the guide catheter 592 is permanently attached to theproximal body 552. Similar to the embodiments described above, the guidecatheter 592 includes an elongate tubular element made of suitablebiocompatible materials including, but not limited to PEEK, Pebax,Nylon, Polyimide, ABS, PVC, polyethylene, etc. The proximal region ofthe tubular element may be covered by a hypotube made of suitablebiocompatible metals or polymers. The proximal end of tubular element isattached to the hub 590. The hub 590 allows the reversible attachment ofthe guide catheter 592 to proximal body 552. In one embodiment, the hub590 is a female luer lock that attaches to a suitable hub on proximalbody 552. Thus, various guide catheters can be attached to the distalregion of proximal body 552 to provide access to various anatomicalregions. The distal end of tubular element may comprise an atraumatictip. In certain embodiments, the distal end of tubular element maycomprise a curved, bent or angled region. It has also been contemplatedthat guide catheter 592 is frictionally fit into the hub 590 such thatthe guide catheter has the ability to rotate within the hub, but stillhave enough friction in the mechanism to allow it to stay in place onceproperly adjusted.

The surgical hand tool 550 shown in FIGS. 9A and 9B allows the user tohold the device in the palm of the hand, balance the device withpreferably the fourth and fifth fingers, and advance the guidewire 558with the index finger and thumb. In this manner, the surgical hand tool550 is held in the same hand that is used to control the guidewire 558.Further, the user has direct access to the guidewire giving full tactilefeel during advance and steering. Balloon catheter 554 advancement isthen achieved by reaching back with the thumb and pushing the balloondriver 560 toward the distal end of the proximal body 552. The guidewire558 can then be retracted using the index finger and thumb, and theballoon catheter 554 can be retracted by pulling the balloon driver 560in the proximal direction.

As shown in FIG. 9A, the fluid line 570 to the balloon inflation port556 is a simple closed system. When the actuation handle 560 is squeezedor moved proximally, the plunger 562 forces fluid from the reservoir 566through the fluid line and into the balloon catheter 554. Moving theactuation handle 560 in the distal direction creates a vacuum to deflatethe balloon of the balloon catheter 544. Alternatively, in someembodiments a spring disposed in or on plunger 562 may act to deflatecatheter 544.

In various embodiments, actuation handle 560 may have any suitableconfiguration and may be spaced at any distance from other components ofhand tool 550, to provide a desired amount of leverage to plunger 562.In some embodiments, plunger 562 may be removable/interchangeable. Forexample, in one embodiment a first size of plunger 562 may be used toprovide high pressure to inflate balloon catheter 544, and a second sizeof plunger 562 may be used to provide high flow to irrigation fluid toan irrigation catheter coupled with hand tool 550. In some embodiments,device 550 may include a pressure indicator to monitor pressure inplunger 562. Alternatively or additionally, plunger 562 may include ahard stop to prevent applying pressure beyond a certain point.

In another embodiment as shown in FIG. 9C, the fluid delivery systemincludes two valves. For ease of reference, the proximal body 552 of thedevice has been removed in FIG. 9C. In this embodiment, the ballooncatheter has been replaced with an open ended device 600 (open at thedistal end) including an inflation port 602. The device 600 can be usedto create a vortex or delivery fluid to a specific region. A fluid line604 is connected between the fluid barrel 564 and the inflation port 602and is also in communication with a separate fluid bath 606. The fluidline includes a first valve 608 adjacent the fluid bath 606 and a secondvalve 610 adjacent to the device 600. In one embodiment, both the firstand second valves are one-way valves. By forcing the plunger 562proximally, by squeezing the handle, the fluid in the fluid barrel 564is pushed through the fluid line 604 and through the second valve 610and into the open ended device 600 (a vortex creating device or otherfluid delivery device). The first one-way valve 608 prevents fluid fromexiting out into the fluid bath 606. Moving the plunger 562 in thedistal direction causes fluid to be drawn from the fluid bath 606 andthrough the first one-way valve 608. The second one-way valve 610prevents air, fluid, etc., from being drawn into the fluid line from thedevice 600. In this system, the fluid barrel 564 can be filled from thefluid bath 606 and emptied through the device 600 “continuously” bymoving the plunger back and forth (or proximally and distally).

Another embodiment of a fluid delivery system is shown in FIG. 9D. Inthis embodiment, the fluid line 604 is unattached to the open endeddevice 600 and connected to the fluid barrel 562 and the separate fluidbath 606. Initially, the fluid line 604 is attached to the secondone-way valve 610 and unattached to the device 600, and fluid is drawnfrom the fluid bath 606 by moving the plunger 562 in the distaldirection. Air can be removed through the second one-way valve 610 bypushing the plunger 562 in the proximal direction. Once all of the airin the system is removed, the fluid line 604 can be detached from thesecond one-way valve 610 and attached to the device 600. Once attachedto the device 600, the plunger 562 may be moved proximally to send fluidinto and through the device. The second one-way valve 610 prevents thefluid from exiting into the fluid bath 606. It has also beencontemplated that a T-valve can be used in place of the first one-wayvalve to remove the need to detach the fluid line from the device 600.

Yet another embodiment of a fluid delivery system is shown in FIG. 9Eand is connected to a balloon catheter 620 including an inflatableballoon 622 and an inflation port 624. As shown in FIG. 9E, the fluidline 604 is connected to a T-valve 626 having a first 628, second 630and third 632 valve. To fill the fluid barrel 564, the plunger 562 ismoved distally to draw fluid from the fluid bath 606 into the fluid line604 through the first one-way valve 608. To remove air in the fluid line604, the first valve 628 is open, the second valve 630 is closed, andthe third valve 632 of the T-valve 626 is open and leads to the secondone-way valve 610, which acts as a vent. With this configuration, theplunger 562 is moved proximally to force air in the fluid line 604 outthrough the second one-way valve 610. Once the air in the system isremoved, the balloon 622 can be inflated by first opening the secondvalve 630 and closing the third valve 632. The first valve 628 remainsopen. With this configuration, the plunger is moved proximally to forcethe fluid through the T-valve 626 and into the balloon catheter 620 toinflate the balloon 622. The system can be arranged in otherconfigurations with other valves to fill the fluid barrel 654 with fluidand remove air from the system by moving the plunger 562 in a back andforth motion (proximally and distally).

Referring now to FIGS. 10A-10E, alternative embodiments of a surgicalhand tool 700 are shown, which allow one handed control of the balloonsinuplasty device. The surgical hand tool 700 includes first and secondrails 702 that replace the proximal body of the surgical hand toolsdescribed above. These rails 702 may be made of biocompatible materials,including, but not limited to ABS, nylon, polyurethane, polyethylene,etc. Use of rails 702 at the proximal end of the hand tool 700 reducesthe profile of the hand tool 700, giving more freedom for the user'sindex finger and thumb to advance a guidewire 703. A balloon catheter704 is positioned parallel to the rails 702, and a balloon inflationport 706 of the balloon catheter 704 is secured by a balloon driver 708of the surgical hand tool 700. Specifically, the balloon inflation port706 is secured within a friction-fit slot 709 of the balloon driver 708,as shown in FIG. 10A. In another embodiment, the balloon inflation port706 is secured within a latch 711 of the balloon driver 708, as shown inFIG. 10B. The balloon driver 708 rides along the rails 702 to advance orretract the balloon catheter 704, which provides relatively lowfriction. As shown in FIG. 10A, the balloon driver 708 includes a T-bar710 that can be grasped by the user's index finger and thumb to advanceor withdraw the balloon catheter. FIG. 10B shows another embodiment ofthe balloon driver 708 that includes a ring 712 for the user to graspand advance or withdraw the balloon catheter 704. Balloon inflation port706 is connected to a suitable inflating device (not shown) via aninflation tubing to inflate the balloon of balloon catheter 704. In thisembodiment, the balloon catheter 704 is introduced into a desired regionof the anatomy over the guidewire 703.

The surgical hand tool 700 also includes a wire retention member 714having a loop 716 for retaining the guidewire 703. Also, proximal endsof the rails 702 are attached to the wire retention member 714 toprevent the rails 702 from moving or twisting. In use, the guidewire 703is fed through the loop 716, over a wire ramp 718, and into the ballooncatheter 704. The guidewire 703 is positioned above the rails 702 of thehand tool 700, allowing a user to control the guidewire 703 behind theguide catheter using a thumb and index finger. The loop 716 prevents theguidewire 703 from drifting to the left or right, and the wire ramp 718keeps the position of the guidewire 703 and is used to hold theguidewire 703 during balloon catheter advancement. The guidewire 703enters the balloon catheter 704 through an opening 720 on the side ofthe balloon catheter 704. This type of catheter, such as a rapidexchange catheter, is known in the art.

The distal ends of the rails 702 are connected to a suitable hub 722that allows a guide catheter 724 to attach to the surgical hand tool700. In this embodiment, the guide catheter 724 includes an elongatetubular element 726 made of suitable biocompatible materials including,but not limited to PEEK, Pebax, Nylon, Polyimide, ABS, PVC,polyethylene, etc. The proximal region of the tubular element 726 may becovered by a hypotube made of suitable biocompatible metals or polymers.The proximal end of tubular element 726 is attached to the hub 722. Thehub 722 allows the reversible attachment of the guide catheter 724 tosurgical hand tool 700. The distal end of tubular element 726 mayinclude an atraumatic tip 728. In certain embodiments, the distal end oftubular element 726 may comprise a curved, bent or angled region.

As shown in FIG. 10A, a handle 730 may be attached to the rails 702 ofthe surgical hand tool 700. The handle 730 is gripped preferably by thefourth and fifth fingers of the user for stabilization. When holding thedevice, the user's palm is preferably pressed against a back portion ofthe handle 730 for stabilization. In one embodiment shown in FIG. 10C, aconnecting member 732 is attached to the handle 730, and the connectingmember 732 is malleable or includes a spring element. A palm brace 734is attached to the other end of the connecting member and is used tobrace the surgical hand tool 700 against the user's palm for supportwhen advancing the guidewire 703 or the balloon catheter 704. The usercan bend or move the connecting member 732 into any position or shapedesired to accommodate orientation preferences. In this embodiment,holding the brace allows the user to lightly place one or two fingers inthe handle 730 to hold the surgical hand tool 700. Also, the springstructure of the connecting member 732 helps absorb some of the shockand motion the surgical hand tool 700 will experience while wiring thesinus.

The surgical hand tool 700 shown in FIG. 10A or 10C allows the user tohold the device in the palm of the hand, balance the device withpreferably the fourth and fifth fingers, and advance the guidewire 703with the index finger and thumb. In this manner, the surgical hand tool700 is held in the same hand that is used to control the guidewire 703.Further, the user has direct access to the guidewire 703, giving fulltactile feel during advancing and steering of the guidewire. Ballooncatheter 704 advancement is then achieved by reaching back with thethumb and pushing the balloon driver 708 forward (distally). Theguidewire 703 can then be retracted using the index finger and thumb,and the balloon catheter 704 can be retracted by pulling the balloondriver 708 in the proximal direction.

Another embodiment of the surgical hand tool 700 is shown in FIGS. 10Dand 10E. In this embodiment, the guide catheter 724 is attached to aguide attachment 736 that is snap-fit into a guide snap 738 having afirst flange 740 and a second flange 742. The flanges 740 and 742 arecloser together in distance than the diameter of the guide attachment736. The flanges 740 and 742 flex to let the guide attachment 736 enterinto the guide snap 738 and then flex back to capture the guideattachment 736. Also, as best shown in FIG. 10E, a recess 744 isprovided proximal to the flanges 740 and 742 to accept a proximal disc746 of the guide attachment 736. This embodiment provides a more securehold of the guide catheter 724.

As shown in FIG. 10E, the balloon driver 708 in this embodiment includesa moveable handle 748. The moveable handle 748 is attached to theballoon driver 708 by an axle 750, which allows the moveable handle 748to swing from one side to another. A spring pin 752 located on theballoon driver 708 snaps into a hole 754 located on the moveable handle748 when the moveable handle 748 is moved from one side to the other.

Also, as shown in both FIGS. 10D and 10E, the surgical hand tool 700 inthis embodiment includes a wire ramp 756 that is formed wire or plasticattached to the handle 730. The first and second rails 702 of thisembodiment are also moved closer together, and may even come intocontact with one another. Having two rails 702 close together preventsrotation of the balloon driver 708 and reduces the profile of thesurgical hand tool 700.

Referring now to FIG. 11, another embodiment of a surgical hand tool 780is shown that includes a front fluid delivery system for deliveringfluid for inflating the balloon of a balloon catheter (not shown). Inthis embodiment, the surgical hand tool 780 includes a syringe barrel782 connected to a mount 784 that is attached to a distal end of aproximal body 786 of the surgical hand tool 780 on an axle 788. As themount 784 rotates about the axle 788, the syringe barrel 782 is drivenup toward a plunger 790 attached to the proximal body 786 on axle 792.Along with allowing the plunger 790 to rotate about axle 792, the axle792 also slides along slot 794 formed in the proximal body 786. Whenaxle 792 slides distally, the axles 792 and 788 move closer together,and the mechanical advantage of plunger 790 and syringe barrel 782system increases, but the “throw,” which is the movement of the barrel782 up along the plunger 790, decreases. In the reverse, when axle 792slides proximally along the slot 794, the axles 792 and 788 move fartherapart, and the mechanical advantage decreases while the throw increases.In operation, the user can rotate the syringe barrel 782 in acounter-clockwise direction to move the barrel 782 toward the plunger790 and force fluid out of the barrel 782 and through an elongate tube796 that is attached to an outlet 797 of the barrel 782. The elongatetube 796 is also attached to a balloon inflation port 798 of the ballooncatheter at the other end. There is a spring (not shown) in the syringebarrel 782 below the plunger 790 that drives the system back to a startposition when the syringe is released.

Referring now to FIGS. 12A and 12B, a side-loaded irrigation catheter820 is shown for use with any of the surgical hand tools 400, 440, 490,510, 550, 700 or 780 described above. The irrigation catheter 820includes a side cut-out or window 822 for guidewire access. A distalsection 824 of the irrigation catheter 820 may include a single lumenwith side holes 826 at a distal end. There may also be a marker 828,such as a radiopaque marker or any other type of marker, disposed at thedistal end of the distal section. The marker 828 informs the user of thelocation of the distal end of the irrigation catheter 820. The length ofthe distal section 824 can vary from about 1 to 4 inches.

Attached to a proximal end of the distal section 824 of the irrigationcatheter 820 is a dual lumen extrusion 830. FIG. 12B shows across-section view of the dual lumen extrusion 830 that includes a firstround lumen 832 for the guidewire and a second crescent lumen 834 forfluid or saline flow. At a transition between the dual lumen extrusion830 and the distal section 824, the irrigation catheter 820 transitionsfrom the dual lumen to the single lumen. Both lumens of the dual lumenextrusion 830 open into the single lumen of the distal section 824 toallow guidewire access and fluid flow to the distal end of the distalsection. The dual lumen extrusion 830 extends to a proximal end of theirrigation catheter 820 and is at least partially covered by asupporting hypotube 836. Hypotube 836 may be similar to a hypotube on aballoon catheter to allow for smooth advancement through the surgicalhand tools described above. As shown in FIG. 12A, the side cut-out 822is through the wall of the supporting hypotube 836 and through the wallof the dual lumen extrusion 830 so that a guidewire can extend into theirrigation catheter 820 and the first round lumen 832. A marker band 838may also be disposed on the supporting hypotube 836 such a distance fromthe distal end of the irrigation catheter to inform the user when thedistal end is exiting the guide catheter. At a proximal end of thesupporting hypotube 836 is a hub 840 for connecting a syringe to theirrigation catheter 820 to flush fluid through the catheter. In thisembodiment, only one port is needed and can be in any orientation.

In another embodiment of the irrigation catheter 820, a flap or valve(not shown) may be disposed inside the single lumen of the distalsection 824 to prevent fluid from flowing back proximally into the firstround lumen 832 of the dual lumen extrusion 830.

Referring now to FIG. 13, a side-loaded irrigation catheter 850 is shownfor use with any of the surgical hand tools 400, 440, 490, 510, 550, 700or 780 described above. In one embodiment, the irrigation catheter 850includes one lumen for greater fluid flow. A side cut-out, window oropen channel 852 is provided on the irrigation catheter. A distalsection 854 of the irrigation catheter 850 may include a single lumenwith side holes 856 at a distal end. Any number of side holes can beprovided at the distal end. There may also be a marker 858, such as aradiopaque marker or any other type of marker, disposed at the distalend of the distal section. The length of the distal section 854 can varyfrom about 1 to 4 inches.

Attached to a proximal end of the distal section 854 of the irrigationcatheter 850 is a single lumen extrusion 860. The single lumen extrusion860 extends to a proximal end of the irrigation catheter 850 and is atleast partially covered by a supporting hypotube 866. Hypotube 866 maybe similar to a hypotube on a balloon catheter to allow for smoothadvancement through the surgical hand tools described above. As shown inFIG. 13, the side cut-out 852 is through the wall of the supportinghypotube 866 and through the wall of the single lumen extrusion 860 sothat a guidewire can extend into the irrigation catheter 850. Anirrigation syringe 868 can also extend into the irrigation catheter 850through the cut-out 852 to flush fluid through the catheter. A markerband may also be disposed on the supporting hypotube 866 such a distancefrom the distal end of the irrigation catheter to inform the user whenthe distal end is exiting the guide catheter. At a proximal end of thesupporting hypotube 866 is a hub 870 for connecting a syringe to theirrigation catheter 820 to flush fluid through the catheter. In thisembodiment, only one port is needed and can be in any orientation. Inanother embodiment, the elongate tube of the distal section 854 mayextend to the proximal end of the irrigation catheter without the havinga single lumen extrusion or a supporting hypotube. In this embodiment,the cut-out 852 would extend through the elongate tube near its proximalend.

The distal section of the irrigation catheter can be disposed on thedistal end of a balloon catheter instead of being a separate device asshown in FIGS. 12A and 13. A balloon catheter with an irrigation distalend 880 is shown in FIGS. 14A and 14B, and allows a physician to flushthe sinus after dilation without having to remove the balloon catheter.The balloon irrigation catheter 880 is for use with any of the surgicalhand tools 400, 440, 490, 510, 550, 700 or 780 described above. A sidecut-out, window or open channel 882 is provided on the balloonirrigation catheter 880. A distal irrigation section 884 may be attachedto the distal end of a balloon catheter 885 and includes a single lumenwith side holes 886 as best shown in FIG. 14B. Any number of side holescan be provided on the distal irrigation section 884. There may also bea marker 888, such as a radiopaque marker or any other type of marker,disposed at the distal end of the distal irrigation section. The lengthof the distal irrigation section 884 can vary from about 1 to 4 inches.

Attached to a proximal end of the distal irrigation section 884 is theballoon catheter 885, which includes an inflation member 889. Theballoon catheter 885 includes a dual lumen tubing 890 having across-section similar to that shown in FIG. 12B, with a first roundlumen and a second crescent lumen. In this embodiment, the first roundlumen can accommodate the guidewire and/or syringe to flush fluid intothe target area. The second crescent lumen can be the inflation lumenfor inflating the inflation member or balloon 889. The dual lumen tubing890 extends to a proximal end of the balloon irrigation catheter 880 andmay even include a supporting hypotube 896 at least partially coveringthe dual lumen tubing 890. Hypotube 896 allows for smooth advancementthrough the surgical hand tools described above. The side cut-out 882 isthrough the wall of the supporting hypotube 896 and through the wall ofthe dual lumen tubing 890 so that a guidewire can extend into theballoon irrigation catheter 880. An irrigation syringe 898 can alsoextend into the irrigation catheter 850 through the cut-out 852 to flushfluid through the catheter. The irrigation syringe 898 may include abent steel hypotube or flexible polymer extrusion. An outer diameter ofthe irrigation syringe should be small enough to fit within the sidecut-out 882 of the balloon irrigation catheter 880. Also, the irrigationsyringe 898 includes a blunt distal tip (not shown) that is dull toavoid cutting or scratching the inner lumen of the balloon irrigationcatheter 880.

A marker band may also be disposed on the supporting hypotube 896 such adistance from the distal end of the balloon irrigation catheter 880 toinform the user when the distal end is exiting the guide catheter. Also,a second marker band may be disposed such a distance from the distal endof the balloon irrigation catheter to indicate when the inflation member889 has exited the guide catheter. At a proximal end of the supportinghypotube 896 is a hub 900 for connecting a syringe to the balloonirrigation catheter 880 to flush fluid through the catheter.

In operation, a user may insert the balloon irrigation catheter 880along a guidewire into a sinus. The inflation member 889 of the balloonirrigation catheter can be inflated once it is in the proper position todilate the sinus. After dilation, the guidewire can be removed from theballoon irrigation catheter, and the irrigation syringe 898 can beinserted into the side cut-out 882. The irrigation syringe 898 is sliddistally in the balloon irrigation catheter 880 so that its end iswithin the closed section of the lumen within the catheter 880. Onceproperly inserted into the balloon irrigation catheter 880, fluid, suchas saline, can be injected through the balloon irrigation catheter usingthe irrigation syringe 898 so that fluid will exit the side holes 886 ofthe distal irrigation section 884.

In yet another embodiment, an irrigation catheter can be sized such thatit fits through the side cut-out of a balloon catheter and into the wirelumen of the balloon catheter. FIGS. 15A and 15B depict a ballooncatheter 910 and an irrigation syringe 912 that is used to flush thesinus after dilation. A side cut-out, window or open channel 914 isdisposed on the balloon catheter 910 and provides an opening forinserting the irrigation syringe 912. The irrigation syringe includes abent steel hypotube or flexible polymer extrusion 916 with a porousballoon 918 mounted at the distal end of the hypotube 916. When fluid isinjected into the irrigation syringe 912, porous balloon 918 expands toopen pores 919 and then fluid flows out of the pores. Once the pressurefrom the fluid is removed, the porous balloon 918 collapses so that theirrigation syringe 912 can be removed from the balloon catheter 910.

As shown in FIG. 15A, the balloon catheter 910 includes an inflationmember 920. The balloon catheter 910 also includes a dual lumen tubing922 having a cross-section similar to that shown in FIG. 12B, with afirst round lumen and a second crescent lumen. In this embodiment, thefirst round lumen can accommodate the guidewire and/or irrigationsyringe 912 to flush fluid into the sinus. The second crescent lumen canbe the inflation lumen for inflating the inflation member or balloon920. The dual lumen tubing 922 extends to a proximal end of the ballooncatheter 910 and may even include a supporting hypotube 924 at leastpartially covering the dual lumen tubing 922. Hypotube 924 allows forsmooth advancement through the surgical hand tools described above. Theside cut-out 914 is through the wall of the supporting hypotube 924 andthrough the wall of the dual lumen tubing 922 so that the guidewireand/or irrigation syringe 912 can extend into the balloon catheter 910.An outer diameter of the irrigation syringe 912 should be small enoughto fit within the side cut-out 914 of the balloon catheter 910. Also,the irrigation syringe 912 includes a blunt distal tip 926 that is dullto avoid cutting or scratching the inner lumen of the balloon irrigationcatheter 910.

The surgical hand tools 400, 440, 490, 510, 550, 700 or 780 describedabove can each be used in a similar manner for dilating an anatomicalregion. In use, the surgical hand tool is introduced into a head of apatient, typically through a nostril but in alternative embodimentsthrough another opening such as a canine fossa puncture. In oneembodiment, an endoscope may be first inserted through a nostril of apatient, followed by insertion of a guide catheter. In otherembodiments, the endoscope and guide catheter can be inserted together.The endoscope and guide catheter are positioned such that the distal tipof guide catheter is located near an anatomical region to be accessedand the endoscope can view the targeted anatomical region. Thereafter,the guidewire is introduced through the guide catheter such that thedistal tip of the guidewire is located at or near the targetedanatomical region. During this step, the guidewire may be navigatedthrough the anatomy using the torquing device of the guidewire. In oneembodiment, the guidewire is positioned across a paranasal sinus ostiumto be dilated. Thereafter, the balloon catheter is advanced over theguidewire into the anatomy by pushing the slide or balloon catheterdriver in the distal direction. Once the balloon of the balloon catheteris correctly positioned, the balloon catheter is used to perform adiagnostic or therapeutic procedure. In one embodiment, the ballooncatheter is used to dilate an opening leading to a paranasal sinus suchas a paranasal sinus ostium. Once the procedure is complete, theendoscope and surgical hand tool 400, 440, 490, 510, 550, 700 or 780 areremoved from the targeted anatomical region and the patient.

FIG. 16 illustrates one embodiment of a method for using a hand tool400, 440, 490, 510, 550, 700 or 780 such as those described above. As afirst step, a guide with a balloon catheter disposed in its lumen isheld with one hand via a handle. The guide, with the balloon catheterinside it, is then advanced into a human or animal subject. Thisadvancement may be into a nostril or through some other access pathway,such as through a canine fossa puncture into a maxillary sinus. In someembodiments, the method may include forming a manmade opening into aparansal sinus, such as a canine fossue puncture, before the advancingstep. In various embodiments, the guide/catheter combination may beadvanced before, during or after an endoscope is advanced into thesubject through the same or a different access route.

When the guide is positioned at a desired location in the subject, suchas with its distal end near a paranasal sinus ostium, in someembodiments the balloon catheter may be advanced out of the guide toposition a balloon of the catheter in the sinus opening. Someembodiments may optionally include an additional step of advancing aguidewire out of the guide and then advancing the balloon catheter outof the guide over the guidewire. Once the balloon of the ballooncatheter is in a desired location relative to the opening of theparansal sinus ostium, the balloon may then be expanded to dilate theopening. The guide and balloon catheter may then be removed from thesubject.

A number of different variations may be made to the above-describedmethod in various embodiments. For example, as described further above,in some embodiments an endoscope may also be attached to the handle suchthat the guide, balloon catheter and endoscope may be advanced into thesubject at the same time. In some embodiments, alternatively, just theguide is coupled with the handle, the balloon catheter is preloaded inthe guide and handle, and the guidewire is preloaded in the ballooncatheter. In some embodiments a lighted guidewire may be used, in whichcase the guidewire may be illuminated during any suitable portion of theprocedure. Some embodiments of the method may also include an irrigationprocedure, in which an irrigation catheter is advanced into a paranasalsinus and used to flush mucus and/or other material out of the sinus.Thus, as has been described in greater detail above, in variousalternative embodiments the method of the present invention may includea number of different steps and variations.

In all of the embodiments above, the guidewire used can be anyconventional guidewire. It has also been contemplated that anilluminating guidewire device can also be used, such as the devicedisclosed in U.S. patent application Ser. No. 11/522,497, now U.S. Pat.No. 7,559,925, issued on Jul. 14, 2009, which is herein incorporated byreference. The illuminating guidewire device is connected to a lightsource and includes an illuminating portion at a distal end thatilluminates. Illumination of the illuminating guidewire device can beused to visually confirm the positioning of a distal end portion of anilluminating device placed within a patient. In use, a distal endportion of an illuminating device is inserted internally into a patient,and emits light from the distal end portion of the illuminating device.Then, the physician can observe transillumination resulting from thelight emitted from the distal end portion of the illuminating devicethat occurs on an external surface of the patient, which correlates thelocation of the observed transillumination on the external surface ofthe patient with an internal location of the patient that underlies thelocation of observed transillumination. This confirms positioning of thedistal end portion of the illuminating device.

Any of the sinuplasty devices and systems 200, 250, 300, 370, 400, 440,490, 510, 550, 700, 780, 820, 850, 880, 910 and 912 can be packaged orkilted ready for use. In this embodiment, the device or system would beplaced in a single package for a physician to open immediately beforethe procedure or surgery. In certain embodiments, different types ofkits can be packed with various instruments, for example, straightand/or curved guide catheters. In this way, kits can be prepared forspecific procedures, such as for use in the maxillary sinus or use inthe frontal sinus. Various kits may be provided, such as but not limitedto “complete” and “partial” kits. In one embodiment, for example, acomplete kit may include a guide catheter, an illuminating guidewire, aballoon catheter, and an integrated inflation device. Optionally, anirrigation catheter, extra or different guidewire, extra or differentballoon catheters and/or the like may be included. A partial kit, in oneembodiment, may include balloon catheter integrated with a handle andinflation device. A guide catheter, illuminating guidewire, irrigationcatheter and/or the like may be provided as separate packets or thelike. Of course, any combination of the various devices and elementsdescribed in this application may be kilted together in variousalternative embodiments. In some embodiments, a kit may also include anendoscope, such as a swing prism endoscope. Such swing prism endoscopesare described in greater detail in U.S. Patent Application No.61/084,949, entitled Swing Prism Endoscope, and filed Jul. 30, 2008, nowexpired, the full disclosure of which is hereby incorporated byreference.

The device may also be packaged with the various devices of the systemintegrated together and ready for use once the device or system isremoved from the package. For example, the balloon catheter can bepositioned within the guide catheter. Also, the inflation device mayalready be attached to the balloon catheter in the package in certainembodiments, unless it eases fluid preparation to have the inflationdevice unattached. The suction lumen can also be attached to the guidecatheter, and the fluid lumen can be attached to the endoscope, inembodiments that include the endoscope packaged together with the deviceor system. Further the guide catheters can be connected to the proximalbody of the devices 200, 250, 400, 440, 490, 510, 550, 700 and 780. Forthe balloon sinuplasty and endoscope integration systems 300 and 370,the endoscope can be pre-attached to the guide catheter. In otherembodiments, though, the endoscope may not be packaged with the deviceor the integrated system. This would allow the physician to choose apreferred endoscope for use during the procedure or surgery.

Packaging the devices and systems for immediate use saves the physiciantime in preparation and setup of the devices and systems 200, 250, 300,370, 400, 440, 490, 510, 550, 700, 780, 820, 850, 880, 910 and 912. Thedevices and systems can be sterilized before packaging and will not needto be flushed in preparation for surgery. The physician should only haveto plug in fluid lumens and attach a light cable to the endoscope beforeuse of the kitted systems. For the packages including the surgical handtools 200, 250, 400, 440, 490, 510 550, 700 or 780, the physician mayalso have to choose and prepare an endoscope for the procedure if one isnot provided in the kit. Also, in certain embodiments, a guidewire canbe included with the kit, and even positioned within the ballooncatheter and guide catheter of the device of systems. However, in otherembodiments, the guidewire is not included in the packaged kit, and thephysician may choose a preferred guidewire to perform the procedure.

The rigid or flexible endoscopes disclosed herein may have a range ofview ranging from 0 degrees to 145 degrees. The embodiments ofendoscopes comprising a curved, bent or angled region may bemanufactured by curving or bending the optical fibers before fusing theoptical fibers. The optical fibers may be fused for example by heatingthem to a temperature ranging from 500 to 700 degrees Celsius or byusing suitable epoxy adhesives to attach the optical fibers to eachother. The endoscopes may be made using reduced cladding thicknessoptical fibers to allow curved, bent or angled regions with a largeangle or curvature but a small radius of curvature. The endoscopes mayalso be made using glass/glass/polymer (GGP) multimode fiber such as theones made by 3M to allow curved, bent or angled regions with a largeangle or curvature but a small radius of curvature. For example, inembodiments of endoscopes that have a bent, curved or angled regionenclosing an angle of 90 degrees or more, the radius of curvature of thebent, curved or angled region may preferably be less than or equal to1.5 cm. Such endoscopes comprising curved, bent or angled regions with alarge angle or curvature but a small radius of curvature are especiallyuseful to enable a user to access the maxillary sinuses.

The embodiments herein have been described primarily in conjunction withminimally invasive procedures, but they can also be used advantageouslywith existing open surgery or laparoscopic surgery techniques. Forexample, the methods and devices disclosed herein may be combined withone or more techniques of Functional Endoscopic Sinus Surgery (FESS). InFESS, a surgeon may remove diseased or hypertrophic tissue or bone andmay enlarge the ostia of paranasal sinuses to restore normal drainage ofthe sinuses. It is typically performed with the patient under generalanesthesia using endoscopic visualization.

Although FESS continues to be the gold standard therapy for severesinuses, it has several shortfalls such as post-operative pain andbleeding associated with the procedure, failure to relieve symptoms in asignificant subset of patients, risk of orbital, intracranial andsinonasal injuries, etc. Replacing one or more steps of FESS may reducethe shortfalls associated with the traditional FESS. The following aresome examples of procedures involving a combination of FESS and theprocedures disclosed in this patent application and the patentapplications incorporated herein by reference.

1. In one combination procedure, a maxillary sinus is treated by balloondilation with or without total or partial removal of the uncinate. Totalor partial removal of the uncinate may make it easier or faster for somephysicians to visualize and access the maxillary sinus.

2. In another combination procedure, a maxillary sinus is treated byballoon dilation in conjunction with removal of a nasal turbinate.During this combination procedure, a part or the entire nasal turbinatee.g. the middle turbinate may be removed. Removing a part or the entiremiddle turbinate provides additional working space in the region medialto the uncinate for instruments. This may potentially make thecombination procedure easier or faster.

3. In another combination procedure, a sphenoid sinus ostium is treatedby balloon dilation in conjunction with ethmoidectomy. The step ofethmoidectomy may enable a physician to introduce a guide catheterthrough the middle meatus to the sphenoid sinus ostium. This maypotentially enable easy access to the sphenoid sinus ostium.

4. In another combination procedure, a frontal sinus is treated byballoon dilation in conjunction with middle turbinate resection and/orethmoidectomy. This combination procedure may make easier for aphysician to find, visualize or access the frontal sinus once anatomicalstructures like Ethmoid bulla, turbinate, etc. are removed or reduced.

5. In another type of combination procedures, multiple sinuses aretreated by balloon dilation with no or minimal tissue or bone removal.This is then followed by standard techniques to treat sinus disease.Examples of such combination procedures include:

5A. Frontal, maxillary, or sphenoid sinuses are treated by balloondilation. Also, ethmoidectomy is performed while preserving theuncinate. The presence of the uncinate may preserve the natural functionof the uncinate. This in turn may lead to lower incidence ofcomplications like infection, etc. in the sinuses.

5B. Any paranasal sinus may be treated by balloon dilation combined witha second procedure including, but not limited to ethmoidectomy,septoplasty, reduction of a turbinate (e.g. inferior turbinate, middleturbinate, etc.), etc.

6. Any of the procedures disclosed herein may be performed inconjunction with irrigation and suction of one or more paranasal sinuseswith a flexible catheter or rigid instrument. A flexible catheter isparticularly useful to reach regions that are difficult to access byrigid instruments. Such regions may be located in lateral aspects of thefrontal sinuses, the inferior or medial aspects of the maxillarysinuses, etc.

7. Any of the procedures disclosed herein may further include removal ofone or more polyps. Polyp removal by standard techniques such as usingshavers can be combined with balloon dilation of various paranasal sinusostia. Once one or more polyps are removed, one or more ostia ofparanasal sinuses may be dilated by balloon dilation.

8. In another type of combination procedures, balloon dilation of one ormore paranasal sinus ostia may be performed to revise a previouslyperformed surgery or in conjunction with standard endoscopic sinussurgery techniques. Examples of such procedures include:

8A. Treating scar formation over frontal recess: In this combinationprocedure, an attempt is made to access frontal recess with a guidewire.A balloon catheter is then passed over the guidewire. If the guidewireis unable to access the frontal sinus ostia because of scarring orbecause the frontal sinus ostia are too small, a surgical instrumente.g. curette or seeker may be used to open or puncture scar tissue oradhesions or the frontal sinus ostia. Such scar tissue or adhesions maybe caused for example due to infection, prior surgery, etc. Thereafter,the frontal sinus ostia may be dilated by balloon dilation.

8B. Combination procedures similar to the abovementioned combinationprocedure may be performed to treat scarring near sphenoid sinuses andmaxillary sinuses.

9. In another type of combination procedures, one or more paranasalsinuses e.g. a maxillary sinus may be accessed by an artificiallycreated opening leading to the sinuses. Thereafter, a diagnostic ortherapeutic procedure disclosed herein or in the patent documentsincorporated herein by reference may be performed. The artificiallycreated opening may be used to endoscopically visualize the placement ofdevices such as balloon catheters, guidewires, or other devices througha natural ostium of the paranasal sinus. The artificially createdopening may also be used to introduce one or more diagnostic,therapeutic or access devices. The artificially created opening may beused to introduce liquids including, but not limited to solutions ofantibiotics, solutions of anti-inflammatory agents, etc. Theartificially created opening may be made by using suitable devicesincluding, but not limited to drilling devices, chopping devices,puncturing devices, etc.

Some specific examples of hybrid procedures of the present invention areshown in the flow diagrams of FIGS. 17-20.

FIG. 17 shows steps in a method wherein an anatomical or pathologicalstructure, such as the uncinate process, a turbinate, the wall of anethmoid air cell, a polyp, etc. is removed or substantially modified anda dilator (e.g., the balloon of a balloon catheter) is positioned withinan opening of a paranasal sinus and used to dilate that opening. Removalor modification of the anatomical or pathological structure may provideclearer access to and/or visibility of certain anatomical structuresduring the procedure or during post-operative examinations andfollow-up.

FIG. 18 shows steps in a method where a dilator such as the balloon of aballoon catheter is positioned in the opening of a paransal sinus andused to dilate that opening and, either before or after such dilation,the cavity of the paranasal sinus is suctioned or irrigated. In caseswhere a balloon catheter or other dilator device having a through lumenis used to accomplish the dilation step, the irrigation and/or suctionstep may be carried out by passing fluid or negative pressure throughthe through lumen of the dilation catheter. Or, a guidewire may beadvanced into or near the sinus cavity during the dilation step and,thereafter, a suction and/or irrigation device may be advanced over suchguidewire and used to carry out the suction and/or irrigation step.

FIG. 19 shows steps in a method where scar or adhesion tissue has formedin a location that obstructs a lumen, orifice, or passageway (e.g., scartissue obstruction the opening of a paranasal sinus) and a puncturetract is initially formed in the scar or adhesion tissue. This may beaccomplished by pushing a needle, seeker, probe, guidewire or otherpenetrator through the tissue. Thereafter, a dilator (e.g., a ballooncatheter) is advanced into the puncture tract and is used to dilate thepuncture tract, thereby relieving the obstruction caused by the aberrantscar or adhesion tissue.

FIG. 20 shows steps in a method wherein a dilator (e.g., the balloon ofa balloon catheter) is placed in a pre-existing opening of a paranasalsinus, such as the natural ostium of the sinus (or a previouslysurgically altered ostium) and is used to dilate that opening. Also, aseparate opening is created in that paranasal sinus, either from thenasal cavity or through the exterior of the face (e.g., a bore hole,antrostomy or trephination). This may provide improved ventilationand/or drainage of the sinus cavity. Optionally, the two openings maythen be used to perform other procedures. For example, “flow through”irrigation may be carried out by passing irrigation solution through oneof the openings and out of the other. Or, a device may be insertedthrough one of the openings, leaving the other opening unobstructed. Or,the physician may visualize (e.g., through an endoscope) through thenewly created opening while treated the pre-existing opening orperforming other diagnosis or treatment of the sinus cavity.

The devices and methods of the present invention relate to the accessingand dilation or modification of sinus ostia or other passageways withinthe ear nose and throat. These devices and methods may be used alone ormay be used in conjunction with other surgical or non-surgicaltreatments, including but not limited to the delivery or implantation ofdevices and drugs or other substances as described in co-pending U.S.patent application Ser. No. 10/912,578 entitled Implantable Devices andMethods for Delivering Drugs and Other Substances to Treat Sinusitis andOther Disorders filed on Aug. 4, 2004, now U.S. Pat. No. 7,361,168,issued on Apr. 22, 2008, the entire disclosure of which is expresslyincorporated herein by reference.

The invention has been described with reference to certain examples orembodiments, but various additions, deletions, alterations andmodifications may be made to these examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unsuitable for its intendeduse. All reasonable additions, deletions, modifications and alterationsare to be considered equivalents of the described examples andembodiments and are to be included within the scope of the followingclaims.

What is claimed:
 1. A device for dilating an ostium of a paranasal sinusof a human or animal subject, the device comprising: (a) a handlecomprising a proximal end and a distal portion; (b) an elongate guideshaft extending distally from the handle, wherein the elongate guideshaft defines a guide shaft lumen, said elongate shaft comprising aproximal portion and a distal end, wherein the distal end comprises apreformed fixed bend; (c) a guidewire slidably positioned within theguide shaft lumen; (d) a dilator configured to transition between anon-expanded configuration and an expanded configuration, wherein thedilator is configured to fit in an ostium of a paranasal sinus in thenon-expanded configuration, wherein the dilator is longitudinallyslidable relative to the elongate guide shaft and relative to theguidewire; and (e) a first slide member coupled with the dilator,wherein the first slide member is located between the proximal end andthe distal portion of the handle, wherein the first slide member isslidable relative to the handle, wherein the first slide member isoperable to slide the dilator longitudinally relative to the elongateguide shaft past the preformed fixed bend to a position that is distalof a tip of the elongate guide shaft without dilating the dilator,wherein the preformed fixed bend is configured to not change shape asthe dilator moves past the preformed fixed bend.
 2. The device of claim1, wherein the dilator is slidably positioned within the guide shaftlumen.
 3. The device of claim 1, further comprising a second slidemember coupled with the guidewire, wherein the second slide member isslidable relative to the handle, wherein the second slide member isoperable to slide the guidewire longitudinally relative to the elongateguide shaft.
 4. The device of claim 3, wherein the second slide memberis further operable to rotate the guidewire relative to the elongateguide shaft.
 5. The device of claim 1, wherein the elongate guide shaftdefines a longitudinal opening extending from the guide shaft lumen toan outer surface of the elongate guide shaft.
 6. The device of claim 5,wherein the elongate guide shaft further includes a distal end and aproximal end, wherein at least one end of the longitudinal openingterminates at a longitudinal position located between the distal end andthe proximal end of the elongate guide shaft.
 7. The device of claim 5,wherein the first slide member is coupled with the dilator through thelongitudinal opening.
 8. The device of claim 1, wherein the handledefines a longitudinal opening.
 9. The device of claim 8, wherein thefirst slide member is coupled with the dilator through the longitudinalopening.
 10. The device of claim 1, further comprising a piercing membercoupled with a distal end of the elongate guide shaft, wherein thepiercing member is configured to pierce a hole into a paranasal sinus,wherein the distal end of the elongate guide shaft is configured to fitthrough a hole formed by the piercing member.
 11. The device of claim 1,further comprising a fluid reservoir in fluid communication with thedilator.
 12. The device of claim 11, further comprising an actuatorcoupled with the fluid reservoir, wherein the actuator is operable todrive fluid from the fluid reservoir to the dilator to thereby inflatethe dilator into the expanded configuration.
 13. The device of claim 1,wherein the bend comprises a curve.
 14. The device of claim 1, whereinthe bend comprises an oblique angle.
 15. The device of claim 1, whereinthe elongate guide shaft has a distal end, wherein the first slidemember is operable to position a distal portion of the dilator distal tothe distal end of the elongate guide shaft.
 16. A device for dilating anostium of a paranasal sinus of a human or animal subject, the devicecomprising: (a) a handle comprising a proximal end, wherein the handledefines a laterally presented slot located distal relative to theproximal end; (b) an elongate guide shaft extending distally from thehandle, wherein the elongate guide shaft defines a guide shaft lumen,wherein the elongate guide shaft comprises a distal end wherein thedistal end comprises a fixed bend; (c) a guidewire slidably positionedwithin the guide shaft lumen; (d) a dilation device comprising a dilatorshaft, a dilator, and a sliding member, wherein the sliding member isconfigured to slide relative to the handle, wherein the sliding memberis disposed within the laterally presented slot defined by the handle,wherein the dilator is configured to transition between a non-expandedconfiguration and an expanded configuration, wherein the dilator isconfigured to fit in an ostium of a paranasal sinus in the non-expandedconfiguration, wherein the dilator is longitudinally slidable past thefixed bend and out of a distal end of the elongate guide shaft, whereinthe fixed bend is configured to not change shape as the dilator movespast the fixed bend, wherein the dilatation device is slidable relativeto the guidewire; and (e) a hub positioned between the elongate guideshaft and the handle.
 17. The device claim 16, further comprising aslide member slidably disposed relative to the handle, wherein the slidemember is coupled with the dilator, wherein the slide member is operableto slide the dilator relative to the elongate guide shaft.
 18. A devicefor dilating an ostium of a paranasal sinus of a human or animalsubject, the device comprising: (a) a handle comprising a proximal endand a distal end, wherein the handle defines a channel between theproximal end and the distal end; (b) an elongate guide shaft extendingdistally from the handle, wherein the elongate guide shaft defines aguide shaft lumen, wherein the elongate guide shaft has a distal endwith a preformed fixed bend; (c) a guidewire slidably positioned withinthe guide shaft lumen; (d) a dilator configured to transition between anon-expanded configuration and an expanded configuration, wherein thedilator is configured to fit in an ostium of a paranasal sinus in thenon-expanded configuration, wherein the dilator is longitudinallyslidable relative to the elongate guide shaft and relative to theguidewire; (e) an inflation port, wherein the inflation port is in fluidcommunication with the dilator; and (f) a slide member comprising aportion which extends laterally from the channel at a locationin-between the proximal end and the distal end of the handle, whereinthe slide member is mechanically coupled to the dilator such that thedilator is configured to slide longitudinally relative to the elongateguide shaft in response to longitudinal advancement of the slide member.